Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.

Device Description

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental device called "Mondial" (preformed plastic denture tooth). This type of document declares substantial equivalence to a predicate device and does not contain the kind of detailed study information requested in your prompt.

Therefore, I cannot provide the information you've asked for, such as:

A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria.
Sample size used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
Adjudication method for the test set: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present, as this typically applies to AI-assisted diagnostic devices.
If a standalone performance (algorithm only) was done: Not present.
The type of ground truth used: Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

This letter solely confirms that the "Mondial" denture teeth are substantially equivalent to previously marketed devices and are cleared for marketing based on their intended use in the fabrication of full and partial dentures. The "study" referenced in 510(k) submissions typically refers to non-clinical tests (e.g., material properties, dimensional stability) or comparisons to predicate devices, rather than clinical efficacy studies with human subjects that would generate the data you're asking about for AI/diagnostic devices.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

Public Health Service

MAY 2 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060994

Trade/Device Name: Mondial Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: April 10, 2006 Received: April 12, 2006

Dear Ms. Zimmerman:

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.

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Page 2 - Ms. Cheryl V. Zimmerman

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 S. Lin, PhD

Chiu S. Lin. PhD 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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Page 1

510(k) Number (if Known):

Device Name: Mondial

2060994

Indications For Use:

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

Concurrence of CDRH, Office of Device evaluation (ODE) sthesiology, General Hospital, Control, Liental Devices OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.