SOLITAIRE 2 by HERAEUS KULZER, INC.

Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. This oonlant is designed for filling of the classes I, II, and V according to Black. It also can be pred for splinting of teeth which are traumatically loose, restoration of primary teeth and reconstruction of stumps. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

Device Description

Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.

AI/ML Overview

The provided text is a letter from the FDA regarding the "Solitaire® 2" dental restoration device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, allowing it to be marketed.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance
Sample size used for the test set and data provenance
Number of experts and their qualifications for ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study details
Standalone performance details
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

This document is a regulatory approval letter, not a scientific study report or performance evaluation.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1999

Ms. Cheryl V. Zimmerman, Manager Quality Operations & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re : K993932

Solitaire® 2 Trade Name: Regulatory Class: II Product Code: EBF November 17, 1999 Dated: November 18, 1999 Received:

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerninq your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Zimmerman

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041, or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known): K874300 K993932

Device Name: Solitaire 2

Indications For Use:

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Rumper

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number.

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.