BISCOVER LED

K051999 · Bisco, Inc. · EBD · Aug 22, 2005 · Dental

Device Facts

• Record ID: K051999
• Device Name: BISCOVER LED
• Applicant: Bisco, Inc.
• Product Code: EBD · Dental
• Decision Date: Aug 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface. BISCOVER LED is used to Seal and Polish: 1. Direct composites (cured) 2. Indirect composites 3. Provisionals 4. Acrylic appliances 5. Resin-modified Glass Ionomers 6. Enamel before or after orthodontic bracket placement 7. Etched Enamel

Device Story

BISCOVER LED is a low-viscosity, light-cured multifunctional acrylate resin used by dental professionals to seal and polish dental restorations and enamel. The material is applied to the surface and cured using standard LED dental curing lights. Its proprietary chemistry allows for polymerization without an oxygen-inhibited layer, resulting in a smooth, polished surface that reduces or eliminates the need for manual polishing. The device is intended for use in a clinical dental setting. By providing a sealed, smooth surface, it protects restorations and enamel, potentially improving the longevity and aesthetics of dental work.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to confirm the device is non-toxic.

Technological Characteristics

Light-cured, multifunctional acrylate resin. Low-viscosity liquid form factor. Polymerization initiated by standard LED dental curing lights. No oxygen-inhibited layer formation.

Indications for Use

Indicated for sealing and polishing direct/indirect composites, provisionals, acrylic appliances, resin-modified glass ionomers, and enamel (including pre/post orthodontic bracket placement and etched enamel). No specific age or gender restrictions.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• BISCOVER LV (K043168)

Submission Summary (Full Text)

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# AUG 2 2 2005

# 12051494

## Section 5 510 (k) SUMMARY

| Applicant: | Bisco, Inc. |
|----------------------|------------------------------|
| | 1100 W. Irving Park Road |
| | Schaumburg IL, 60193 |
| Contact Person: | Benjamin Lichtenwalner |
| | Tel: [phone] |
| | Fax: [phone] |
| Date Prepared: | July 20, 2005 |
| Trade Name: | BISCOVER LED |
| Common Name: | Surface Sealant |
| Classification/Name: | Tooth Shade Resin Material |
| | Class II per 21 CFR 872.3310 |

#### Description of Applicant Device:

BISCOVER LED is a low viscosity, light-cured resin formulation used to seal restorations and etched cnamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LED cures without any sticky oxygen-inhibited layer. BISCOVER LED may reduce or even eliminate the need for manual polishing. The photo-initiator used by BISCOVER LED allows most LD demal curing lights to achieve polymerization.

#### Intended uses of Applicant Device:

BISCOVER LED is used to seal and polish direct composites (cured), indirect composites, provisionals, acrylic appliances, Resin-Modified Glass Ionomers, Enamel before or after orthodontic bracket placement, and etched Enamel.

Predicate Devices: BISCOVER LV (K043168) dated February 1, 2005.

## Significant Performance Characteristics:

#### BISCOVER LED to BISCOVER LV

| Property | BISCOVER LV | BISCOVER LED |
|------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended use | Resin sealant | Resin sealant |
| Chemical composition | Light-Cured, Multifunctional<br>Acrylate Resin | Light-Cured, Multifunctional<br>Acrylate Resin |
| Mechanical /physical<br>properties | Low viscosity clear resin liquid<br>light cured to smooth polish<br>surface | Low viscosity clear resin liquid<br>light cured to smooth polish<br>surface |

Side by side comparisons of BISCOVER LED to the predicate device BISCOVER LV clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LED was tested for biocompatibility and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LED.

Page 5-1

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Image /page/1/Picture/11 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 2 2005

Mr. Benjamin Lichtenwalner _. Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K051999

Trade/Device Name: Biscover LED Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: July 22, 2005 Received: July 25, 2005

Dear Mr. Lichtenwalner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaled in in 1 ( ) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } referenced above and harro to legally marketed predicate devices marketed in interstate commerce use stated in the enoroure) to regist date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nate been roetablics and require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereore, manter the act include requirements for annual registration, listing of devices, good economic provision, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your de how ho easy additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Benjamin Lichtenwalner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Simon Purre
Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):

Device Name: BISCOVER LED

Indications for Use: 「 ~· · · · · ·

\$

BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.

1105 1999

BISCOVER LED is used to Seal and Polish:

- 1. Direct composites (cured)
- 2. Indirect composites
- 3. Provisionals
- 4. Acrylic appliances
- 5. Resin-modified Glass Ionomers
- 6. Enamel before or after orthodontic bracket placement
- 7. Etched Enamel

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ke- Mulay for MSR

Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number: K051999