ARTEGRAL AND POLYSTAR SELECTION

K030588 · Merz Dental GmbH · ELM · May 7, 2003 · Dental

Device Facts

• Record ID: K030588
• Device Name: ARTEGRAL AND POLYSTAR SELECTION
• Applicant: Merz Dental GmbH
• Product Code: ELM · Dental
• Decision Date: May 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Artegral, and Polystar® Selection are intended for use as teeth in dentures.

Device Story

Artegral and Polystar Selection are preformed plastic denture teeth. They are fabricated from polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN). These devices are used by dental professionals as components in the construction of complete or partial dentures to restore patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only. Performance and safety testing conducted against recognized standards to establish reliability; biocompatibility testing performed.

Technological Characteristics

Materials: Polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN). Form factor: Preformed plastic denture teeth. Characteristics are comparable to predicate devices.

Indications for Use

Indicated for use as teeth in dentures for patients requiring prosthetic tooth replacement.

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.

Predicate Devices

• Dental Vipi Ltda: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth (K022300)

Submission Summary (Full Text)

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K030588

## S :ction 3.0 510(k) Summary

| Submitted by: | Merz Dental GmbH<br>Eetzweg 20<br>D-24321 Luetjenburg<br>Germany<br>Phone: + 49.4381.4030<br>Fax: + 49.4381.403100 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | This summary was prepared on February 20, 2003. |
| Device name: | Artegral, and Polystar Selection |
| Common Name: | Preformed Plastic Denture Teeth |
| Classification Name: | Denture, Plastic, Teeth: 21 CFR §872.3590, ProCode 76 ELM |
| Predicate Devices: | Dental Vipi Ltda: Acry Pan, Vipi Dent Plus, Biolux, Biolux V,<br>New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V<br>Preformed Plastic Denture Teeth (K022300). |
| Modifications: | Differences in available size, shape, and color. |
| Intended Use: | Artegral, and Polystar® Selection are intended for use as teeth<br>in dentures. |
| Technological<br>Characteristics: | Comparable chemical composition as the predicate. |
| Testing: | Performance and safety testing activities were conducted<br>against recognized standards to establish the reliability<br>characteristics of the new devices. Testing involved bench<br>studies, and biocompatibility tests. |

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Image /page/1/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" arranged around the perimeter. In the center of the seal are three stylized human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2003

Merz Dental GmbH C/O Mr. James Delaney EXPERTech Associates, Incorporated 100 Main Street, Suite 120 Concord, Massachusetts 01742

Re: K030588

Trade/Device Name: Artegral and Polystar Selection® Performed Plastic Denture Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: February 21, 2003 Received: February 25, 2003

Dear Mr. Delaney:

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 - Mr. Delaney

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 vour 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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Susie Runner

Susan Runner, DDS, MA Interim 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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## Indications for Use Statement

51 J(k) Number (if known)

K030588 ______________________________________________________________________________________________________________________________________________________________________

Device Name

Merz Dental GmbH Artegral, and Polystar® Selection preformed plastic denture teeth

Indications for Use Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.

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