When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.

Device Description

TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental device, comparing it to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing with a defined sample size, ground truth, or expert evaluation.

The provided text focuses on establishing substantial equivalence based on intended use, chemical composition, and mechanical/physical properties compared to existing legally marketed devices, rather than a clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria because the provided text does not contain this type of data.

Specifically, the document states: "Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder." This indicates a comparison for substantial equivalence and biocompatibility testing, not a performance study with acceptance criteria.

Summary

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K042804

FEB - 1 2005

Page 5-1

Section 5 510 (k) SUMMARY

Applicant: Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193

Contact Person: Benjamin Lichtenwalner Tel: 847-534-6146 Fax: 847-534-6111
Date Prepared: October 8, 2004

Trade Name:	TESCERA Opaquer/Sculpting Resin and Opaquer Powder
Common Name:	Dental Opaquing/Masking Composite and Wetting Resin
Classification/Name:	Tooth Shade Resin MaterialClass II per 21 CFR 872.3690

Description of Applicant Device:

Intended uses of Applicant Device:

TESCERA Opaquer/Sculpting Resin is intended for wetting instruments to aid in the placement and shaping of composites. TESCERA Opaquer/Sculpting Resin mixed with TESCERA Opaquer Powder is a dual-cured (light and/or heat cured) tooth colored opaquing/masking composite system intended for masking the materials used in dental prostheses.

TESCERA Opaquer Powder and Opaquer/Sculpting Resin are optimized for use with the TESCERA ATL (Aqua-Thermal-Light) system.

Predicate Devices:

D/C OPAQUER (a.k.a. Opaquer Resin), cleared under Bisco Porcelain Repair Kit (K874557) dated January 28, 1988.

MODELING RESIN (a.k.a. Sculpting Resin), cleared under Sculpting Resin (K030585) dated May 2, 2003.

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Section 5 510 (k) SUMMARY (continued)

Significant Performance Characteristics:

D/C OPAQUER to TESCERA Opaquer/Sculpting Resin and Opaquer Powder

Property	D/C OPAQUER	TESCERAOpaquer/Sculpting Resinand Opaquer Powder
Intended use	Substrate Opaquer/Masker	Substrate Opaquer/Masker
Chemical composition	Dual cure (light and self), filled, dimethacrylate composite	Dual cure (heat and light), filled, dimethacrylate composite
Mechanical /physical properties	Low viscosity, tooth colored, paste-to-paste opaquer/masker	Low viscosity, tooth colored, powder-to-resin opaquer/masker

MODELING RESIN to TESCERA Opaquer/Sculpting Resin

Property	MODELING RESIN	TESCERA
		Opaquer/Sculpting Resin
Intended use	Wetting of composite instruments	Wetting of composite instruments
Chemical composition	Light cured, filled, dimethacrylate composite	Dual cured (heat/light), unfilled, dimethacrylate resin
Mechanical /physical properties	Slightly viscous, straw colored, instrument wetting agent	Low viscosity, light yellow, instrument wetting agent

Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder.

Page 5-2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The text is in all capital letters and is smaller than the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2005

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

Re: K042804

Trade/Device Name: TESCERA Opaquer/Sculpting Resin and Opaquer Powder Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 22, 2004 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 the Federal 9 000g, Drag, Drag, 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. 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 moun that 1 Drima made 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 and listing (21 et read on), equality 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) rins leter notification. The FDA finding of substantial equivalence of your device to a premainer nourseans and in a classification for your device and thus, permits vour 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 (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Ko42804 510 (k) Number (if known):

TESCERA Opaquer/Sculpting Resin and Opaquer Powder Device Name:

Indications for Use:

TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.

When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.

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

Over-The-Counter Usc (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)

Susan Runge
(Division Sign-Off)
Division of Anesthesiology

Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(K) Number K042804

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.