CERGOGOLD

K993897 · Degussa - Ney Dental, Inc. · EIH · Jan 10, 2000 · Dental

Device Facts

• Record ID: K993897
• Device Name: CERGOGOLD
• Applicant: Degussa - Ney Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Jan 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is used in the manufacture of all-ceramic dental restorations. The product is in the form of pellets and is processed with currently marketed furnaces.

Device Story

Cergogold is a ceramic core material supplied as pellets; intended for use in the fabrication of all-ceramic dental restorations. The material is processed using currently marketed dental furnaces to form the final restoration. The device is used by dental laboratory professionals to create custom dental prosthetics. The final restoration is placed by a dentist to restore tooth function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ceramic core material supplied in pellet form; processed via standard dental furnaces.

Indications for Use

Indicated for use as a ceramic core material in the manufacture of all-ceramic dental restorations.

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

## JAN 1 0 2000

Mr. Andrew J. Pietrobono Operations Manaqer Nev Dental, Incorporated Porcelain Division 1065 S.W. 30th Avenue Deerfield Beach, Florida 33442-8193

K993897 Re : Trade Name: Cerqoqold Regulatory Class: II Product Code: EIH Dated: December 17, 1999 Received: December 20, 1999

Dear Mr. Pietrobono:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): K993897

Device Name: Cergogold

Indications For Use:

material Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over The -Counter Use

(Optional Format 1-2-96)

Susan Runnes

(Division Sign-Off)
Division of Dental Infection Control