DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLILNTS 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 Description

UNINHIBITED contains Hexafunctional Urethane Acrylate (30.6%), Polyethylene Glycol (400) Diacrylate (61.4%), phosphine oxide, diphenyl (Photoinitiator) 8.0% 4-methyl methacrylate (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration.

AI/ML Overview

The provided text does not contain information on acceptance criteria, device performance, sample size, ground truth establishment, or details about a study to prove the device meets acceptance criteria. The document is a 510(k) premarket notification for a dental sealant called "UNINHIBITED," establishing its substantial equivalence to a predicate device ("Fortify"). It details the device description, intended use, and a comparison table with the predicate device, but no performance studies or specific acceptance criteria are mentioned beyond biocompatibility.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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AUG 01 2002

Section 5-1

Image /page/0/Picture/3 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 zig-zag pattern. Each hexagon contains a letter, spelling out the company name "BISCO".

Image /page/0/Picture/5 description: The image shows a handwritten text string. The string appears to be "K021503". The characters are written in a simple, somewhat stylized manner, with some connections between the letters and numbers. The image is in black and white, with the text standing out against the white background.

Bisco, Inc.

1100 W. Irving Park Road, Schaumburg, IL. 60193 U.S.A Telephone: (847) 534-6000 or 1-800-BIS-DENT Fax: (847) 534-6396 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: Common Name: Classification name:

UNINHIBITED

Surface Sealant Material, Tooth Shade, Resin

Class II per 21 CFR 872.3690

Description of Applicant Device:

Intended uses of Applicant Device:

The principle use of UNINHIBITED is to seal the surface of:

Direct Composite Restorations, Indirect Composite Restorations, Provisional Restorations, Amalgam Restorations, Enamel Surfaces around Orthodontic Brackets, Processed Acrylic Prostheses-Removable Partial & Complete Dentures and Maxillofacial Prostheses, Processed Acrylic Appliances-Orthodontic Retainers, Lingual Retainers and Extracoronal Splints

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

	UNINHIBITED	FORTIFY
Intended Use	Resin sealant.	Resin sealant.
ProductDescription	Clear solution.	Clear solution.
Delivery System	Brush	Brush

Side by side comparisons of UNINHIBITED to the predicate device FORTIFY clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of UNINHIBITED 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 UNINHIBITED.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

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

Re: K021503

Trade/Device Name: Uninhibited Regulation Number: 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: May 07, 2002 Received: May 09, 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 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.

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.

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Page 2 - Mr. Smith

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothe A. Ulatowski

Timothy A. Ulatowski 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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of Sec. 2

			V UT
	510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________	t	1

Device Name: UNINHIBITED

Indications For Use: TO SEAL THE SURFACE OF:

(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)

Susan Purre

(Division Sign-Off) Division of Dental, Infection Control, a - Caneral Hospital Devices 1 Number _ 1000 30

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
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.(b)
Classification. Class II.