PRE-VISION FILL by HERAEUS KULZER, INC.

I apologize, but the provided text does not contain detailed information about acceptance criteria, device performance results, study design, or expert qualifications for a medical device. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for a device called "PreVision Fill."

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for marketing it. It mentions the product's trade name, regulatory class, and product code, but does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes, data provenance, ground truth establishment methods, or whether the study was retrospective or prospective.
Information on the number or qualifications of experts used for ground truth.
Adjudication methods.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was conducted or its effect size.
If a standalone (algorithm-only) performance study was done.
The type of ground truth used (e.g., pathology, outcomes data).
The sample size for the training set or how its ground truth was established.

The "Indications For Use" section on page 2 states that the device is for "All temporary fillings and temporary restorations using inlay and onlay restorations," but this is an intended use, not performance criteria or study results.

Therefore, I cannot provide the requested information based on the text provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a stylized bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

Ms. Cheryl V. Zimmerman Manager Quality Operations and Regulatory Affairs Heraeus Kulzer, Inc. 4315 S. Lafayette Blvd. South Bend, Indiana 46614-2517

K993602 Re: PreVision Fill Trade Name: Requlatory Class: II Product Code: EBF Dated: October 22, 1999 Received: October 25, 1999

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, Drug, 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 registration, listing of devices, qood 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 concerning 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

A. 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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Page 1 of

510(k) Number (if Known):

Device Name: Prevision® FILL

Indications For Use:

All temporary fillings and temporary restorations using inlay and onlay restorations.

(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) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Runne

(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.