GENERAL INFORMATION

BisCover is a light-cured resin formulation used to seal restorations while leaving a smooth polished/glazed surface. Due to its unique proprietary chemistry, BisCover cures without any sticky oxygen-inhibited layer. BisCover may reduce or even eliminate the need for manual polishing. When a very thin layer is desired, the viscosity of BisCover can be reduced by using the Viscosity Modifier. The unique chemistry of BisCover prefers a conventional halogen curing light to achieve polymerization. The Ultra-Lume^™ LED 5 is the only LED curing unit known to cure BisCover. Plasma-arc (PAC) curing lights can also cure BisCover (See section "What is EOP?").

BisCover is used to Seal and Polish/Glaze:
1. Direct composites (both cured and uncured)
2. Indirect composites
3. Provisionals
4. Acrylic appliances
5. Enamel before or after orthodontic bracket placement

A. On Cured Composite:

1. Contour composite.

2. Apply acid etchant, such as UNI-ETCH^®* w/BAC, TO COMPOSITE AND ADJACENT TOOTH STRUCTURE for 15 seconds.

3. Rinse and dry.

4. Dispense BisCover into a mixing well or apply directly using the syringe and an applicator tip.

NOTE: The Viscosity Modifier may be added to BisCover if a lower viscosity is desired. Do not exceed a 1:1 ratio. Briskly mix for 5 seconds and apply immediately to maintain the low viscosity throughout the application. Allow 15 seconds before light curing to ensure that the solvent has fully evaporated. Do not apply unmixed Viscosity Modifier directly in the mouth.

5. Apply one thin coat of BisCover on cured composite. If needed, air-thin BisCover by blowing a gentle stream of air over this layer to ensure an even distribution.

CAUTION: Upon curing, BisCover may produce a brief exothermic reaction which is minimized by applying in a thin layer. Do not cure on soft tissue.

6. Using a halogen curing unit with a minimum output of 500mW/cm² (7.5J/cm²), light cure for 30 seconds at close range (0-2mm).

NOTE: If the light intensity is lower and/or curing occurs at a distance (10mm) (both commonly occur clinically), light cure for greater than 30 seconds. (See chart in "What is EOP?" section.)

BisCover requires a conventional halogen curing light in order to initiate polymerization. Insufficient curing will leave an air-inhibited layer on the surface of BisCover.

7. If a second coat is required, repeat steps 4-6.

B. On Uncured Composite:

1. Contour uncured composite to final anatomy.

2. Dispense and apply one thin coat of BisCover on uncured composite using a brush applicator. If needed, air-thin BisCover by blowing a gentle stream of air over this layer to ensure an even distribution.

NOTE: Viscosity Modifier should not be used when applying BisCover over uncured composite.

Caution: Upon curing, BisCover may produce a brief exothermic reaction which is minimized by applying in a thin layer. Do not cure on soft tissue.

3. Light-cure according to the composite manufacturer's recommendation.
OR Using a halogen curing unit with a minimum output of 500mW/cm² (7.5J/cm²), light-cure for 30 seconds at close range (0-2mm).

NOTE: If the light intensity is lower and/or curing occurs at a distance (10mm) (both commonly occur clinically), light-cure for greater than 30 seconds. (See chart in "What is EOP?" section.)

BisCover requires a conventional halogen curing light in order to initiate polymerization. Insufficient curing will leave an air-inhibited layer on the surface of BisCover.

4. If a second coat is desired, repeat steps 2-3. If desired, the Viscosity Modifier may be used in the second coat. See "NOTE" for Viscosity Modifier in
section A step 4.

5. If occlusal adjustment is required, reapply BisCover following instructions for cured composite (section A).

C. On Old/Previously-Placed Composites or for Reapplication:

1. Pumice, rinse and dry the restoration.

2. Sandblast surface or roughen with a fine diamond, rinse and dry.

3. Apply acid etchant, such as UNI-ETCH w/BAC, for 15 sec.

4. Rinse with water (approx. 10-20 seconds) and dry thoroughly.

5. Dispense BisCover into a mixing well or apply directly using the syringe and applicator tip.

NOTE: The Viscosity Modifier may be added to BisCover if a lower viscosity is desired. Do not exceed a 1:1 ratio. Briskly mix for 5 seconds and apply immediately to maintain the low viscosity throughout the application. Allow 15 seconds before light curing to ensure that the solvent has fully evaporated. Do not apply unmixed Viscosity Modifier directly in the mouth.

6. Apply one thin coat of BisCover on cured composite. If needed, air-thin BisCover by blowing a gentle stream of air over this layer to ensure an even distribution.

CAUTION: Upon curing, BisCover may produce a brief exothermic reaction which is minimized by applying in a thin layer. Do not cure on soft tissue.

7. Using a halogen curing unit with a minimum output of 500mW/cm² (7.5J/cm²), light cure for 30 seconds at close range (0-2mm).

NOTE: If the light intensity is lower and/or curing occurs at a distance (10mm) (both commonly occur clinically), light cure for greater than 30 seconds. (See chart in "What is EOP?" section.)

BisCover requires a conventional halogen curing light to initiate polymerization. Insufficient curing will leave an air-inhibited layer on the surface of BisCover.

8. If a second coat is desired, repeat steps 5-7.


D. Provisionals and Appliances (Based on Acrylic Resins):

NOTE: For large areas, the use of the Viscosity Modifier with BisCover will allow it to spread more easily and produce a thinner and more even film thickness.

1. Contour the provisional restoration.

2. Rinse and dry. (Etchant is not required.)

3. Dispense BisCover into a mixing well.

NOTE: The Viscosity Modifier may be added to BisCover if a lower viscosity is desired. The ratio of BisCover to Viscosity Modifier should be 1:1. Briskly mix for 5 seconds and apply immediately to maintain the low viscosity throughout the application. Allow 15 seconds before light curing to ensure that the solvent has fully evaporated.

4. Apply one thin coat of BisCover. If needed, air-thin BisCover by blowing a gentle stream of air over this layer to ensure an even distribution.

5. Using a halogen curing unit with a minimum output of 500mW/cm² (7.5J/cm²), light cure each surface for 30 seconds at close range (0-2mm).
NOTE: If the light intensity is lower and/or curing occurs at a distance (10mm) (both commonly occur clinically), light cure for greater than 30 seconds. (See chart in "What is EOP?" section.)

BisCover requires a conventional halogen curing light to initiate polymerization. Insufficient curing will leave an air-inhibited layer on the surface of BisCover.


E. In Orthodontic Applications:

Prior to Bracket Placement:

1. Clean the surface to receive the BisCover/bracket with a slurry of pumice/water.

2. Etch the surface to receive the BisCover with 32% phosphoric acid, such as UNI-ETCH w/BAC for 30 seconds (120 seconds for primary teeth).

3. Rinse with water (approx. 10-20 seconds) and dry thoroughly. The etched area will appear frosty white. If not, re-etch for an additional 20 seconds.

4. Dispense BisCover into a mixing well.

5. With a brush, apply a thin layer of BisCover to the etched enamel.

CAUTION: Upon curing, BisCover may produce a brief exothermic reaction which is minimized by applying in a thin layer. Do not cure on soft tissue.

6. Using a halogen curing unit with a minimum output of 500mW/cm² (7.5J/cm²), light cure the BisCover for 30 seconds per tooth at close range (0-2mm).

NOTE: If the light intensity is lower and/or curing occurs at a distance (10mm) (both commonly occur clinically), light cure for greater than 30 seconds. (See chart in "What is EOP?" section.)

7. Apply desired bracket cement (self-cured, light-cured or dual-cured) to the bracket pad, and place bracket on tooth in the usual manner. (No additional bonding resin is required.)

If Brackets have already been placed:

1. Follow same instructions as in section E, "Prior to Bracket Placement" excluding step 7.

What is EOP?

Energy for Optimization of Polymerization is the minimum amount of energy required to achieve clinically acceptable polymerization. For BisCover, EOP assumes a layer of 5-40µm. EOP assumes the tip of the curing light is 1-2mm away from the surface to be cured. Although this is easily achieved in the laboratory, it is less likely to occur clinically, where the tip is typically held at a distance (i.e. 10mm). EOP also differs with the shade of the material beneath BisCover.

EOP was determined by using a Quartz Tungsten Halogen curing unit (VIP, BISCO, Schaumburg, IL) calibrated with a radiometer. The effective wavelength for the curing light is 400-500nm. The degree of polymerization of cured BisCover is then measured spectroscopically. EOP is then calculated as the energy required (Joules) to reach clinically acceptable polymerization.

NOTE: BisCover absorbs light in the range of 380-440nm. Therefore, most LED curing units will not cure BisCover. A known exception is the Ultra-Lume^™ LED 5 (Ultradent, Jordan, UT). To cure BisCover with the Ultra-Lume LED 5, light cure for 20 sec. at close range (5mm) or 40 sec. at a distance (10mm).

Plasma-arc (PAC) light-curing units, such as the Q-Lux Plasma 100, require 10-15 seconds to cure BisCover.


Calculating Curing Time for BisCover:

Energy delivered to the surface of BisCover depends on the power density of the light, spectral output of the light, exposure time and the distance between the light probe and the BisCover coated surface. As mentioned, the EOP of BisCover is 7,500mJ/cm². The power density of a halogen curing light must first be determined using a radiometer. For example, if the light output (PD, power density) is 500mW/cm², then the calculation is EOP/PD= 7,500/500= 15 seconds.

Although a distance of 1-2mm from the material is easily achieved in the laboratory, it is less likely to occur clinically where the tip is typically held at a distance (i.e. 10mm). The following chart describes the time requirements needed for curing vs. distance from the light guide at various Power outputs.

Based on BisCover's EOP of 7,500mJ/cm²

Using a Light Box for Curing:

BisCover can also be cured in commercially available light curing boxes such as the Triad^® 2000 (Dentsply, York, PA). The preceding chart will help you determine curing time. For most light boxes the power output will be between 7.5-75mW. Refer to the chart as a guide.

Based on BisCover’s EOP of 7,500mJ/cm²

Please note that BisCover cannot be overcured. Therefore, the BisCover coated appliance can be placed back into the processing unit if it is determined that it has not been fully cured.


Troubleshooting:

If cured BisCover is tacky there are 4 possible reasons:

1. The light source is less than the required amount. Bulb output decreases with age. Use a radiometer to determine actual output. Even though a set output has been dialed, many curing units require calibration. Do not rely on dialed-in values, unless they have been calibrated by using a radiometer.

2. The light tip is too far away from the surface. Increase curing time or increase output (PD) to obtain delivery of 7,500mJ/cm² to the BisCover coated surface.

3. When coating uncured composite, BisCover layer may have become contaminated with resin components from the composite. In this case, add a second coat of BisCover and repeat the curing process.

NOTE: When using BisCover over uncured composite DO NOT use Viscosity Modifier. The second coat of BisCover in this technique may be used with Viscosity Modifier.

4. Light does not emit energy at the required wavelength of 380-440nm.


STORAGE: Store at room temperature (22°C/72°F). Refer to individual component labels for specific expiration dates.

PRECAUTIONS: Unpolymerized resins may cause skin sensitization in susceptible persons. In case of contact with the skin, wash thoroughly with soap and water. Do not cure on soft tissue.

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.

* BISCOVER is a trademark of BISCO, Inc.
UNI-ETCH and ONE-STEP are registered trademarks of BISCO, Inc.

BISCO, Inc.
1100 W. Irving Park Rd.
Schaumburg, IL 60193
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-117R4
Rev. 10/07

U.S. Patent: 7,081,485