TYRIAN SPE is a universal, no rinse, self-priming etchant that combines the etchant and primer application into one simple step. It achieves high bond strength to cut and uncut enamel and dentin, equivalent to that achieved with conventional phosphoric acid etchant when used with ONE-STEP^®* PLUS. Since this system is not dependent upon wet/moist bonding techniques, it allows for more predictable clinical results. TYRIAN SPE is less technique sensitive, without sacrificing bond strength. Because there is no need to rinse the etchant before adhesive application, TYRIAN SPE will also save the operator time during the procedure. It is available in a unit-dose which, once activated, may be used for an all-day patient appointment, or for multiple restorations. It is also available in a 2-bottle system, TYRIAN SPE PARTS A & B. The tyrian (purple) color acts as an application indicator, in order to visualize proper coverage of the preparation. After contacting the tooth structure and the excess is blotted from the preparation, the color disappears as TYRIAN SPE is neutralized.

ONE-STEP PLUS Filled Universal Dental Adhesive ONE-STEP PLUS GENERAL INFORMATION

ONE-STEP PLUS, another technological breakthrough from Bisco, is a filled version of the clinically proven ONE-STEP, 5th generation Universal Adhesive System. It is 8.5% filled with a revolutionary proprietary filler with an average particle size of 1µm. ONE-STEP PLUS is designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. Because of its unique chemistry, and its minimal and uniform film thickness, this system is also designed for indirect techniques when used with a cementation medium as well as amalgam bonding. The ONE-STEP Adhesive Systems are truly universal adhesives that have been designed to work with self-cured^1,2, dual-cured and light-cured composite materials.

The principal uses of the TYRIAN SPE & ONE-STEP PLUS SYSTEM, with self-cured, dual-cured or light-cured composite materials, are:
· Direct Restorations.
· Desensitization of Preparations for Indirect Restorations.
· Desensitization of Hypersensitive and/or Exposed Root Surfaces.
· Cementation of Indirect Restorations.
· Surface Sealant.
· Post Cementation.
· Bonding of Orthodontic Brackets.

TYRIAN SPE can also be used with ONE-STEP, a 5th generation Universal Adhesive System and ALL-BOND 2 ®*, a 4th generation Universal Adhesive System.

FIG. 1		FIG.2		FIG.3		FIG.4

1. Shake the unit-dose for 3-5 seconds (FIG. 1) and then slowly press the chambers together (FIG. 2). You will notice a color change to TYRIAN (purple), which will disappear after application and blotting the preparation.

2. Remove cap slowly (FIG. 3) and stir using an applicator or a Foam Pellet* (FIG. 4) to insure a complete mix prior to application.

1. Dispense 1 or 2 drops of TYRIAN SPE PART A into a mixing well. Shake TYRIAN SPE PART B bottle for 3-5 seconds once the mixing element inside the bottle is audible. Hold bottle at a 45° angle and dispense the same number of drops into the same mixing well. You will notice a color change to TYRIAN (purple), which will disappear after application and blotting the preparation.

2. Stir using an applicator or Foam Pellet to insure a complete mix prior to application.

INSTRUCTIONS FOR USE

DIRECT RESTORATIONS

1. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

2. Dry the preparation for at least 5 seconds. Make sure no moist spots remain on the tooth.

3. Apply 2 coats of TYRIAN SPE to the entire surface of the preparation (enamel and dentin) using an applicator (for smaller preparations) or Foam Pellet (for larger preparations). Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Using a Foam Pellet (new or blotted dry original), lightly blot excess from the preparation, leaving it moist and shiny, not matte, in appearance. TYRIAN color should have disappeared.

4. Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

5. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-moistened preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

6. Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

7. Light cure for 10 seconds per surface.

8. Continue with direct restorative treatment using self-cured or light-cured composite materials, such as ÆLITE™*, according to manufacturer's instructions.

DESENSITIZATION OF PREPARATIONS FOR INDIRECT RESTORATIONS

Preparation Appointment: Desensitization

1. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

2. Dry the preparation for at least 5 seconds. Make sure no moist spots remain on the tooth.

3. Apply 2 coats of TYRIAN SPE to the entire surface of the preparation (enamel and dentin) using an applicator (for smaller preparations) or Foam Pellet (for larger preparations). Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Using a Foam Pellet (new or blotted dry original), lightly blot excess from the preparation, leaving it moist and shiny, not matte, in appearance. TYRIAN color should have disappeared.

4.   Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

5. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-moistened preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

6. Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

7. Light cure for 10 seconds per surface.

8. With a moistened 2x2 gauze, remove the oxygen inhibited (sticky) layer from the sealed tooth. This will help prevent the impression material and provisional from adhering to the preparation.

9. Continue with impression making and provisionalization.

Cementation Appointment: Tooth Preparation

10. Remove provisional restoration; clean the preparation and try-in the definitive restoration. Eugenol may affect curing of some composite materials. If eugenol-containing temporary cement was used, clean the preparation with pumice to remove all traces of the cement.

11.   Dispense Tyrian SPE following the Tyrian SPE DISPENSATION INSTRUCTIONS.

12. Dry the preparation for at least 5 seconds. Make sure no moist spots remain on the tooth.

13. Apply 2 coats of TYRIAN SPE to the entire surface of the preparation (enamel and dentin) using an applicator (for smaller preparations) or Foam Pellet (for larger preparations). Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Using a Foam Pellet (new or blotted dry original), lightly blot excess from the preparation, leaving it moist and shiny, not matte, in appearance. TYRIAN color should have disappeared.

14. Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

15. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-moistened preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

16. Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

17. Light cure for 10 seconds per surface.

18. Continue with cementation procedure, using self-cured, dual-cured or light-cured resin cements, such as C&B™*, DUO-LINK™*, or other cementation medium, according to manufacturer's instructions.

DESENSITIZATION OF HYPERSENSITIVE AND/OR EXPOSED ROOT SURFACES

1. Clean dentin surface with a slurry of pumice and a disinfectant such as CAVITY CLEANSER™*.

2. Rinse thoroughly with warm water and blot with a Foam Pellet. Do not air dry but make sure no moist spots remain on the tooth.

3. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

4. Dry the preparation for at least 5 seconds. Make sure no moist spots remain on the tooth.

5. Apply 2 coats of TYRIAN SPE to the entire surface of the preparation (enamel and dentin) using an applicator (for smaller preparations) or Foam Pellet (for larger preparations). Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Using a Foam Pellet (new or blotted dry original), lightly blot excess from the preparation, leaving it moist and shiny, not matte, in appearance. TYRIAN color should have disappeared.

6. Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

7. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-moistened preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

8. Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

9. Light cure for 10 seconds per surface.

10.If desensitization is not achieved, repeat adhesive application (steps 6-9 above).

11. With a moistened 2x2 gauze, remove the oxygen inhibited (sticky) layer from the sealed tooth.

TOOTH PREPARATION FOR CEMENTATION OF INDIRECT RESTORATIONS

1. Remove provisional restorations; clean the preparation and try-in the definitive restoration. Eugenol may affect curing of some composite materials. If eugenol-containing temporary cement was used, clean the preparation with pumice to remove all traces of the cement.

2. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

3. Dry the preparation for at least 5 seconds. Make sure no moist spots remain on the tooth.

4. Apply 2 coats of TYRIAN SPE to the entire surface of the preparation (enamel and dentin) using an applicator (for smaller preparations) or Foam Pellet (for larger preparations). Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Using a Foam Pellet (new or blotted dry original), lightly blot excess from the preparation, leaving it moist and shiny, not matte, in appearance. TYRIAN color should have disappeared.

5. Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

6. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-moistened preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

7.Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

8. Light cure for 10 seconds per surface.

9. Continue with cementation procedure, using self-cured, dual-cured or light-cured resin cements, such as C&B, DUO-LINK, or other cementation medium, according to manufacturer's instructions.

RESTORATION SURFACE SEALANT

1. Following adjustment and finishing of the final restoration, rinse the tooth and restoration with copious amounts of water to remove all debris..

2. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

3. Dry the restoration for at least 5 seconds. Make sure no moist spots remain on the tooth.

4. Using an applicator or Foam Pellet, apply 2 coats of TYRIAN SPE to the entire surface of the restoration and approximately 1-2 mm beyond the tooth/restoration margin. For a full-coverage restoration, apply over the entire surface of the restoration. Allow TYRIAN SPE to dwell for 15-20 seconds, a minimum of 20 seconds over uncut enamel, with agitation on any enamel to make sure the entire surface is covered and etched. Rinse and dry.

5. Apply a surface sealant such as FORTIFY™* or FORTIFY PLUS, according to manufacturer's instructions.
OR If using BisCover™* Liquid Polish, finish and apply BisCover according to manufacturer's instructions. These products will improve marginal integrity and reduce wear and staining.

CEMENTATION OF FIBER AND METALLIC POSTS
POST SPACE PREPARATION

1. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

2. Apply 2 coats of TYRIAN SPE to the canal and to the preparation using an endo applicator (sold separately) and a Foam Pellet.

3.   Blot the canal dry with a large paper point, making sure no moist spots remain. Using a Foam Pellet (new or blotted dry original), blot excess from the preparation, as TYRIAN color disappears.

4. Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

5. Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using an endo applicator (sold separately) and a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-coated canal and preparation, rewetting between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

6. Blot the canal dry with a paper point; repeat with a new paper point until the paper point returns dry from the canal. This step is important for removal of any pooled adhesive to prevent interference in complete seating of the post.

7.      Beginning with a gentle stream, gently but thoroughly air dry to evaporate solvent.
NOTE: After drying, the surface should be shiny with ONE-STEP PLUS visible on the preparation. If not, apply more ONE-STEP PLUS and air dry. An excessively thin layer of ONE-STEP PLUS will not provide maximum bond strength.

8.      Light cure for 10 seconds with a small light tip.

9.      Proceed with post cementation procedures, according to manufacturer's instructions.

BONDING ORTHODONTIC BRACKETS

1. Dispense TYRIAN SPE following the TYRIAN SPE DISPENSATION INSTRUCTIONS.

2. Dry the tooth for at least 5 seconds. Make sure no moist spots remain on the tooth.

3.      Apply 2 coats of TYRIAN SPE to the enamel surface to be bracketed using an applicator (for smaller areas) or Foam Pellet (for larger areas). Only an area slightly larger than the bracket base is required. Agitate TYRIAN SPE over the enamel surface for at least 20 seconds to make sure the entire surface is covered. Using a Foam Pellet (new or original blotted dry), blot excess from the area, as TYRIAN color disappears.

4.      Shake the ONE-STEP PLUS bottle for 3-5 seconds once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator.
NOTE: If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

5.     Hold bottle at a 45° angle and dispense 1-2 drops of ONE-STEP PLUS into a mixing well. Using a bristle brush, apply a minimum of 2 generous coats directly over the TYRIAN SPE-coated enamel surface, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush will require additional coats.

6.     Air dry gently but thoroughly for a minimum of 10 seconds to remove and evaporate excess solvent. Begin with a gentle stream initially and increase to a stronger stream of air.
NOTE: After drying, the surface should be shiny. If not, apply more ONE-STEP PLUS and air dry.

7.    Light cure for 10 seconds per surface.

8.      Apply an orthodontic bonding paste to the retentive side of the bracket base and continue with bracket bonding procedures, according to manufacturer's instructions.

STORAGE: Store at room temperature (22°C/72°F). These products are subject to evaporation; keep bottles tightly capped. See individual component labels for specific expiration dates.

PRECAUTIONS: Avoid splashing into the eyes. If it comes into contact with the eyes, flush with copious amounts of water and seek medical attention. Unpolymerized resins may cause skin sensitization in susceptible persons. In case of contact with the skin, wash thoroughly with soap and water.

WARRANTY: Bisco, Inc. recognizes its responsibility to replace products if proven to be defective. Bisco, Inc. does not accept liability for any damages or loss, either direct or consequential, stemming from the use of or inability to use the products as described. Before using, it is the responsibility of the user to determine the suitability of the product for its intended use. The user assumes all risk and liability in connection therewith.

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a dental professional.

1 Sanares AME, King NM, Itthagarun A, Tay FR, Pashley DH. Adverse surface interactions between one-bottle light-cured adhesives and chemical-cured composites. Dent Mater 2001; 17: 542-556.
2 Swift EJ, Perdigão J, Combe EC, Simpson CH, Nunes MF. Effects of restorative and adhesive curing methods on dentin bond strengths. American Journal of Dentistry 2001; 14:3 137-140.


* TYRIAN, ÆLITE, C&B, DUO-LINK, CAVITY CLEANSER, FORTIFY, and BisCover are trademarks of Bisco, Inc.
ONE-STEP and ALL-BOND 2 are registered trademarks of Bisco, Inc.
Foam Pellets are distributed by Bisco, Inc.
Refer to the ONE-STEP PLUS instructions for use for complete product information.

BISCO, INC.
1100 W. Irving Park Road
Schaumburg, IL 60193
U.S.A.
847-534-6000
1-800-BIS-DENT
www.bisco.com


CE ADMINISTRATOR
Bisico France -
Mr. Fred Picavet
L'Opera- BP. 60
13680 Lançon De Provence
France
Phone: 33-490-42-9292
Fax: 33-490-42-9261


IN-100R4
Rev. 1/07

U.S. Patent: 6,994,551