TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P

K024046 · Bisco, Inc. · EBD · Feb 6, 2003 · Dental

Device Facts

• Record ID: K024046
• Device Name: TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
• Applicant: Bisco, Inc.
• Product Code: EBD · Dental
• Decision Date: Feb 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Intended Use

TO SEAL THE SURFACE OF INDIRECT COMPOSITE RESTORATIONS, BIS ACRYL/ACRYLIC PROVISIONAL RESTORATIONS AND PROCESSED ACRYLIC APPLIANCES.

Device Story

BISCOVER XT/TESCERA GLAZING RESIN is a dental coating material supplied as a clear solution of methyl methacrylate and urethane acrylate. It is applied manually via brush to the surface of indirect composite restorations, bis-acryl/acrylic provisional restorations, and processed acrylic appliances. The device functions as a resin sealant to provide a protective surface finish. It is intended for use by dental professionals in a clinical setting. The device benefits patients by sealing dental restorations and appliances, potentially improving surface integrity and aesthetics.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed on the ingredients to confirm non-toxicity.

Technological Characteristics

Chemical composition: methyl methacrylate and urethane acrylate solution. Delivery method: brush application. Form factor: liquid supplied in a bottle. Class II device (21 CFR 872.3310).

Indications for Use

Indicated for sealing the surface of indirect composite restorations, bis-acryl/acrylic provisional restorations, and processed acrylic appliances.

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

• EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (K014144)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 06 2003

A CONFIDENTIAL

Kozlovic

Section 5-1

#### 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 XT/TESCERA GLAZING RESIN Common Name: GLAZE Classification name: COATING MATERIAL FOR RESIN FILLINGS Class II per 21 CFR 872.3310

#### Description of Applicant Device:

BISCOVER XT/TESCERA GLAZING RESIN is a solution of methyl methacrylate and urethane acrylate supplied in a bottle.

#### Intended uses of Applicant Device:

It is applied with a brush to seal the surface of indirect composite restorations, bis acryl/acrylic provisional restorations and processed acrylic appliances.

Predicate Devices: EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (K014144 manufactured by AFP Imaging Corp.) cleared by FDA on 02/07/2002

### Significant Performance Characteristics:

| | BISCOVER<br>XT/TESCERA<br>GLAZING RESIN | EXTORAL/TESCERA<br>GLAZING RESIN |
|------------------------|-----------------------------------------|----------------------------------|
| Intended Use | Resin sealant. | Resin sealant. |
| Product<br>Description | Clear solution. | Clear solution. |
| Delivery System | Brush | Brush |

Side by side comparisons of BISCOVER XT/TESCERA GLAZING RESIN to the predicate device EXTORAL/TESCERA GLAZING RESIN clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of BISCOVER XT/TESCERA GLAZING RESIN were tested for biocompatibility and were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER XT/TESCERA GLAZING RESIN.

Stephen D. Smith Manager of Regulatory Affairs Bisco, Inc. 847 534 6146

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 6 2003

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

Re: K024046

Trade/Device Name: BIScover™ XT/TESCERA™ Glazing Resin Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: December 04, 2002 Received: December 06, 2002

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 vour 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.

{2}------------------------------------------------

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 vour 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 Runne

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

{3}------------------------------------------------

Page 2 of SEC. 2

2024046 510(k) Number (if known): _

Device Name: BISCOVER XT/TESCERA GLAZING RESIN

Indications For Use:

## TO SEAL THE SURFACE OF INDIRECT COMPOSITE RESTORATIONS, BIS ACRYL/ACRYLIC PROVISIONAL RESTORATIONS AND PROCESSED ACRYLIC APPLIANCES.

(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 Muluy for NSA

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

510(k) Number: