BISCOVER LV

K043168 · Bisco, Inc. · EBD · Feb 1, 2005 · Dental

Device Facts

• Record ID: K043168
• Device Name: BISCOVER LV
• Applicant: Bisco, Inc.
• Product Code: EBD · Dental
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface. BISCOVER LV 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 LV is a low-viscosity, light-cured, multifunctional acrylate resin sealant. Applied by dental professionals to dental restorations and enamel surfaces; cures without oxygen-inhibited layer; eliminates/reduces need for manual polishing. Provides smooth, polished surface finish. Used in clinical dental settings.

Clinical Evidence

Bench testing only. Biocompatibility testing performed; device found to be non-toxic.

Technological Characteristics

Light-cured, multifunctional acrylate resin. Low-viscosity liquid form factor. Polymerization via light-curing. No specific ASTM standards or connectivity features described.

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 noted.

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 Liquid Polish (K030354)

Submission Summary (Full Text)

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Page 5-1

# Section 5 510 (k) SUMMARY

| Applicant: | Bisco, Inc.<br>1100 W. Irving Park Road<br>Schaumburg IL, 60193 |
|----------------------|---------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | November 15, 2004 |
| Trade Name: | BISCOVER LV |
| Common Name: | Surface Sealant |
| Classification/Name: | Coating Material for Resin Fillings<br>Class II per 21 CFR 872.3310 |

#### Description of Applicant Device:

BISCOVER LV is a low viscosity, light-cured resin formulation used to seal restorations and etched enamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LV cures without any sticky oxygen-inhibited layer. BISCOVER LV may reduce or even eliminate the need for manual polishing.

#### Intended uses of Applicant Device:

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

Predicate Devices: BISCOVER Liquid Polish (K030354) dated February 19, 2003.

## Significant Performance Characteristics:

### BISCOVER LV to BISCOVER Liquid Polish

| Property | BISCOVER | BISCOVER LV |
|------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 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 LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LV 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 LV.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, stacked on top of each other.

Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043168

Trade/Device Name: BISCOVER LV Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 24, 2005 Received: January 25, 2005

Dear Mr. Lichtenwalner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting (1 Nr.), It may of buryer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear roublish further announcements concerning your device in the Federal Register.

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# Page 2 - Mr. Lichtenwalner

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act FDA has made a determination that your device complies with other requirements moan that I Dr I has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bakes and squirements, including, but not limited to: registration 1 ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as bet ferin in all of 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) I mis letter will and in Jorde FDA finding of substantial equivalence of your device to a premarket notification - I s 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), If you desire specific at no a compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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):

BISCOVER LV Device Name:

Indications for Use:

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

BISCOVER LV 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Ruma

Offision Sign-Off) ്സടിന്ന Sign-Only
Olvision of Anesthesiology, General Hospital, Inrection Control. Dental Devices

310(k) Number K043161