MONDIAL

K060994 · Heraeus Kulzer, Inc. · ELM · May 22, 2006 · Dental

Device Facts

• Record ID: K060994
• Device Name: MONDIAL
• Applicant: Heraeus Kulzer, Inc.
• Product Code: ELM · Dental
• Decision Date: May 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Mondial synthetic polymer teeth used for fabrication of full and partial dentures; device consists of multi-layered teeth with highly cross-linked enamel/dentine layers for abrasion resistance and less cross-linked base for bonding to denture acrylic; used by dental professionals in clinical/laboratory settings; provides functional and aesthetic replacement for missing teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic polymer denture teeth; multi-layered construction with varying cross-linking density for abrasion resistance and bonding; Class II device (21 CFR 872.3590).

Indications for Use

Indicated for patients requiring full or partial dentures. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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 [phone]. 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 [phone] or [phone] 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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510(k) Number (if Known):

### Device Name: Mondial

2060994

Indications For Use:

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.

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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)