BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER

K030354 · Bisco, Inc. · EBD · Feb 19, 2003 · Dental

Device Facts

• Record ID: K030354
• Device Name: BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
• Applicant: Bisco, Inc.
• Product Code: EBD · Dental
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

TO SEAL THE SURFACE OF: DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLINTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS

Device Story

BISCOVER LIQUID POLISH is a resin-based surface sealant applied via brush to dental restorations and appliances. It functions as a protective coating to seal surfaces of composite, amalgam, and acrylic materials. BISCOVER VISCOSITY MODIFIER (acetone) is provided to adjust the thickness of the polish. Used in dental clinics by practitioners to improve the longevity and finish of restorations and prostheses. The device provides a clear, protective layer, potentially reducing microleakage and improving surface aesthetics for the patient.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed on the ingredients of BISCOVER LIQUID POLISH, confirming they are nontoxic.

Technological Characteristics

Resin-based sealant containing Hexafunctional Urethane Acrylate (30%), Polyethylene Glycol Diacrylate (26%), Ethoxylated Bisphenol A Diacrylate (34%), Trifunctional Acid Ester (3%), TPO (7%), and MEHQ inhibitor (500 ppm). Supplied as a liquid in a bottle for brush application. Viscosity modifier consists of acetone.

Indications for Use

Indicated for sealing surfaces of direct/indirect composite restorations, amalgam restorations, provisional restorations, intracoronal/extracoronal splints, lingual retainers, enamel around orthodontic brackets, processed acrylic prostheses (removable partial/complete dentures, maxillofacial prostheses), and processed acrylic appliances (orthodontic retainers).

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

• Fortify (K882915)

Submission Summary (Full Text)

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K030354

FEB 1 9 2003

Image /page/0/Picture/1 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of six hexagons arranged in a row, with the letters "B", "I", "S", "C", and "O" inside the first five hexagons. Below the hexagons, the text "Specialist In Adhesive and Composite Technology" is printed in a smaller font.

Bisco, Inc.

1100 W. Irving Park Road, Schaumburg, IL. 60193 U.S.A. Telephone: [phone] or 1-800-BIS-DENT Fax: [phone] WEB SITE http://www.bisco.com

## Contact: Stephen D. Smith

SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92

Trade Name:

# BISCOVER LIQUID POLISH KIT, AND BISCOVER VISCOSITY MODIFIER Surface Sealant

Common Name: Classification name:

Material, Tooth Shade, Resin Class II per 21 CFR 872.3690

## Description of Applicant Device:

BISCOVER LIQUID POLISH contains Hexafunctional Urethane Acrylate (30%), Polyethylene Glycol Diacrylate (26%), Ethoxylated Bisphenol A Diacrylate (34%), Trifunctional Acid Ester (3%), TPO (7%), MEHQ (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration. BISCOVER VISCOSITY MODIFIER is acetone and is used to reduce the thickness of the BISCOVER LIQUID POLISH.

#### Intended uses of Applicant Device:

To seal the surface of: direct and indirect composite restorations, provisional restorations, and amalgam restorations.

Predicate Devices: Fortify K882915 cleared by FDA on 08/12/88

# Significant Performance Characteristics:

| | UNINHIBITED | FORTIFY |
|------------------------|-----------------|-----------------|
| Intended Use | Resin sealant. | Resin sealant. |
| Product<br>Description | Clear solution. | Clear solution. |
| Delivery System | Brush | Brush |

Side by side comparisons of BISCOVER LIQUID POLISH to the predicate device FORTIFY clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of BISCOVER LIQUID POLISH were tested for biocompatibility and were found to be nontoxic.

It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LIQUID POLISH.

Stephen D. Smith Manager Regulatory Affairs 847 534-6146

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them that resemble hair or a stylized representation of the human spirit.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 9 2003

Mr. Steve Smith Manager of Regulatory Affairs Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193

Re: K030354

Trade/Device Name: BIScover™ Liquid Polish Kit, BIScover Liquid Polish, And BIScover Viscosity Modifier Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 31, 2003 Received: February 03, 2003

Dear Mr. Smith:

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 controls provisions 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 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. Steve Smith

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 (QS) 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Runer

Susan Runner, DDS, MA Interim 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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Page of

510(k) Number (if known): K030354

BISCOVER LIQUID POLISH KIT, Device Name:__________________________________________________________________________________________________________________________________________________________________ BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER Indications For Use:

TO SEAL THE SURFACE OF:

DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLINTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Kein Muly for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: X 030354