ZIRKONZAHN ICE

K061851 · Zirkonzahn GmbH · EIH · Sep 29, 2006 · Dental

Device Facts

• Record ID: K061851
• Device Name: ZIRKONZAHN ICE
• Applicant: Zirkonzahn GmbH
• Product Code: EIH · Dental
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.

Device Story

Zirkonzahn Ice is a dental material system used by dental professionals to fabricate metal-free restorations. The system processes zirconia-based materials to create single posterior crowns, multiple unit anterior crowns/bridges, inlays, and onlays. The device functions as a restorative material system for dental laboratory or clinical use, enabling the production of durable, aesthetic bonded dental restorations. By providing a metal-free alternative, it benefits patients requiring dental reconstruction while minimizing potential metal sensitivities or aesthetic concerns associated with traditional metal-based restorations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Zirconia-based dental restorative material. Classified under 21 CFR 872.6660, Product Code EIH (Porcelain Powder for Clinical Use).

Indications for Use

Indicated for patients requiring metal-free dental restorations, including single posterior crowns, multiple unit anterior crowns/bridges, inlays, and onlays.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2006

Zirkonzahn GmbH C/O Ms. Donna Marie Hartnett Official Correspondent 67 Main Street Silver Creek, New York 14136

Re: K061851

Trade/Device Name: Zirkonzahn Ice Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 26, 2006 Received: July 5, 2006

Dear Ms. Hartnett:

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 cither 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. Harmett

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" (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/industry/support/index.html.

Sincerely yours.

Chiu Lien, Ph.D.

Chiu Lin, Ph.D. 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

| 510(k) Number (if known): | K061851 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Name: | Zirkonzahn Ice |
| Indications for Use: | Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations. |
| Prescription Use | <div>X</div> (Part 21 CFR 801 Subpart D) |
| AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz DDS for Dr. Susan Renner

siology. General Hospital, r com ( Control, Dental Devices

Number: K061851