ONE-STEP®*
Universal Dental Adhesive
or
ONE-STEP®* PLUS
Filled Universal Dental Adhesive

GENERAL INFORMATION

ONE-STEP/ONE-STEP PLUS (OS/OS+) are technological breakthroughs from BISCO. OS/OS+ are 5th generation (2-step) Universal Adhesives. ONE-STEP PLUS is 8.5% filled with a revolutionary proprietary filler with an average particle size of 1µm. OS/OS+ are designed to bond composite to dentin, enamel1, 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. OS/OS+ are truly universal adhesives that have been designed to work with light-cured, self-cured and dual-cured composite materials.

The principal uses of OS/OS+ are:
1. All Direct Composite Restorations
2. Directed Shrinkage Composite Restorations
3. Desensitization of Crown Preparations Prior to Impression Making/Provisionalization
4. Indirect Restorative Cementation: Metal, Porcelain and Composite
5. Adhesive (Bonded) Amalgam Restorations
6. Fresh Amalgam to Old Amalgam
7. Composite Core Build-Ups
8. Porcelain Repairs
9. Composite to Composite (Repair)
10. Composite to Metal/Set Amalgam (Direct Veneering)
11. Root Desensitization

For optimal performance, use when OS/OS+ are at room temperature. For ONE-STEP PLUS, if needed, invert bottle and tap on hard surface to free agitator. Allow bottle to vent in an upright position prior to dispensation.

HELPFUL HINTS

1. OS/OS+ can be used with bases or liners made of composite, resin-modified glass ionomer or glass ionomer. ZOE bases may inhibit the set of the adhesive or composite. Covering the dentin with a base or liner prior to adhesive application may compromise dentin bonding.

2. In order to facilitate penetration of OS/OS+ adhesive into the dentin and enamel, the tooth surface should be left slightly but visibly moist with water (not saliva). The optimum method of moistening the tooth with water would be the 'blot' technique with a moistened Foam Pellet*. A brief burst of air (2-3 seconds) with an air syringe after rinsing the etchant will also suffice. (Saliva contamination will seriously compromise dentin bonding.)

3. OS/OS+ adhesives contain a monomer, BPDM, dissolved in an acetone solvent. Once 2 coats have been applied to the dentin surface, thorough but gentle air drying for at least 10 seconds should be done to remove excess solvent. Begin with a gentle stream initially and increase to a fairly strong stream of air. Inadequate air drying will not completely evaporate the solvent and may lead to reduced bond strength and post-operative sensitivity.

4. Proper air-drying is extremely important with all bonding procedures but particular attention should be given to air drying of inlay or onlay preparations. Care should be given to avoid pooling of adhesive in the internal line angles. A stream of air should be directed at all line angles to properly thin adhesive. Excessive pooling could interfere with the seating of the definitive restoration.

5. A rubber dam is essential to the success of a porcelain repair. Moisture contamination of porcelain or metal is detrimental. To increase adhesion to exposed metal, a sandblaster is highly recommended for surface roughening. Diamond bur abrasion may not provide enough surface area for proper bonding.

6. Always lubricate the matrix band prior to amalgam bonding procedures to prevent adhesion of amalgam to the band. Hard inlay wax or a crayon works well. Copalite or vaseline are not always dependable and therefore, not recommended.

7. Adhesive (Bonded) Amalgam Restorations require the use of RESINOMER™*, a dual-cured Amalgam Bonding/Luting System (sold separately). RESINOMER bonds tenaciously to OS/OS+ as well as amalgam. Mechanical adhesion is created as amalgam is condensed into the uncured RESINOMER, while chemical adhesion occurs due to the diarylsulfone dimethacrylate (DSDM).


INSTRUCTIONS FOR USE


1. Isolate tooth and prepare the cavity in a conservative manner. Clean the entire surface with a slurry of pumice and a disinfectant, such as CAVITY CLEANSER™*, or water.

2. Etch enamel and dentin using an etchant, such as UNI-ETCH®* w/BAC or ETCH-37™* w/BAC for 15 seconds, or TYRIAN™* SPE, per manufacturer's instructions.

3a. Preferred method: Rinse thoroughly. Remove excess water by blotting the surface with a Foam Pellet, leaving the dentin and enamel visibly moist with a shiny surface.
NOTE: When using ONE-STEP PLUS, shake bottle once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator. If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

3b. Alternative method: Rinse thoroughly. Air dry for 2-3 seconds. Do not allow enamel or dentin to dry for an excessive period of time. Immediately apply a rewetting/desensitizing agent such as AQUA-PREP™* F or water to the enamel and dentin, using a Foam Pellet. Allow dwelling for 20-25 seconds. Blot the preparation dry with a Foam Pellet or gently air dry for 1-2 seconds to remove excess moisture.
NOTE: When using ONE-STEP PLUS, shake bottle once the mixing element inside the bottle is audible. If needed, invert bottle and tap on hard surface to free agitator. If using ONE-STEP PLUS unit-dose, see instructions on pouch for activation. Apply directly. A mixing well is not required.

4. Hold bottle at a 45° angle and dispense 1-2 drops of OS/OS+ into a mixing well. Using a brush, apply a minimum of 2 generous coats to the entire preparation, rewetting brush between coats. Agitate slightly for 10-15 seconds.
NOTE: Use of a flocked brush (e.g., Microbrush™*) will require additional coats.

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

6. Light cure for 10 seconds.
OPTIONAL FOR CLASS V RESTORATIONS
circle: Apply 1-2 additional coats of OS/OS+ to the entire internal surface of the preparation, agitating slightly for 10 seconds. Thoroughly air dry and light cure for 10 seconds.

7. Proceed with restorative treatment.

circle Research indicates a thicker layer of adhesive will help dissipate the effects of tooth flexure2,3 while providing a wet air-inhibited resin layer to help adapt dry, viscous composites.

STORAGE: Store at room temperature (22°C/68°F-25°C/77°F). Refer to individual component labels for specific expiration dates.

PRECAUTIONS: Uncured resins may cause skin sensitization in susceptible persons. Aviod contact with skin. 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. Kanca, J. One-Step bond strength to enamel and dentin. Am J Dent 1997;10:1 5-8.
2. Kemp-Scholte CM, Davidson CL. Marginal integrity related to bond strength and strain capacity of composite resin restorative systems. J Prosthet Dent 1990b;64:658-664.
3. Van Meerbeek, B. Dentine Adhesion: Morphological, physico-Chemical and Clinical Aspects. Thesis, Lenven (Belgium) 1993.

* ONE-STEP and UNI-ETCH are registered trademarks of BISCO, Inc.
RESINOMER, CAVITY CLEANSER, ETCH-37, TYRIAN and AQUA-PREP are trademarks of BISCO, Inc.
Foam Pellets are distributed by BISCO, Inc.
Microbrush is a trademark of Microbrush, Intl.


BISCO, Inc.
1100 W. Irving Park Rd.
Schaumburg, IL 60193
U.S.A.

1-800-BIS-DENT
847-534-6000
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-130R2
Rev. 11/08

U.S. Patents:
5,749,733 & 5,658,963