CZR PRESS LF STAINS

K050920 · Noritake Co., Inc. · EIH · May 11, 2005 · Dental

Device Facts

• Record ID: K050920
• Device Name: CZR PRESS LF STAINS
• Applicant: Noritake Co., Inc.
• Product Code: EIH · Dental
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.

Device Story

CZR Press LF Stains are dental porcelain materials used by dental laboratory technicians to characterize and replicate natural tooth shade variations. The device is applied to dental restorations to achieve aesthetic color matching. It functions as a surface stain/colorant for porcelain restorations. Used in dental laboratory settings; applied by trained technicians. Output is a color-matched dental restoration. Benefits include improved aesthetic outcomes for patients receiving porcelain dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental porcelain powder/stain. Formulated for use with CZR Press LF porcelain systems. Class II device. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental laboratory technicians to replicate natural tooth shade variations using CZR Press LF porcelain.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

MAY 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007

Re: K050920

Trade/Device Name: CZR Press LF Stains Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 11, 2005 Received: April 12, 2005

Dear Mr. Wasserman:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your Section 510(x) premated is substantially equivalent (for the indications for referenced above and have decemblied the devices marketed in interstate commerce tise stated in the encrosure/ to regally manations p Medical Device Amendments, or to devices that prov to May 26, 1970, the chaomism and 67 in ovisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provised application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application Ast., The opper Act (Act) that do hot require approval or a provisions of the Act. The general therefore, market the device, subject to annual registration, listing of devices, good Controls provisions of the nechade prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in the if your device is classified (Sec above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oods on the concerning your device in the Federal Register.

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Page 2 - Mr. Ivan J. Wasserman, Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that 1 271 b issuaired to our device complies with other requirements of the Act or that I Dr. I has muse a dotenulations administered by other Federal agencies. You must comply with all 1 coloral statutes and 10 god and limited to: registration and listing (21 CFR Part 807); an the Ace s requirements) instruments as set forth in the requirements as set forth in the quality iabeling (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) I ms lotter with a a your finding of substantial equivalence of your device to a legally prematice notification. "The starsification 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 ir you active of Compliance at [phone]. Also, please note the regulation entitled, Comace in Orited of Gempharket notification' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general 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,

Clare

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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## Indications for Use

510(k) Number (if known): K050920

Device Name: CZR Press LF Stains

Indications For Use:

For use in replicating shade variations found in natural teeth For use in replicating Shade Variations using CZR Press LF porcelain.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Susan Quay

Sivision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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