ANTAGON PORCELAIN

K982129 · European Dental Imports, Inc. · EIH · Aug 4, 1998 · Dental

Device Facts

• Record ID: K982129
• Device Name: ANTAGON PORCELAIN
• Applicant: European Dental Imports, Inc.
• Product Code: EIH · Dental
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Device Story

Antagon Porcelain is a dental ceramic material used by laboratory technicians to create porcelain veneers for dental prostheses. The material is applied to dental alloy substrates and baked to form porcelain-fused-to-metal restorations. It is compatible with normal-fusing-temperature dental ceramic alloys. Following fabrication and finishing by the technician, the dentist approves and places the final prosthesis in the patient's mouth. The device serves as a restorative material to replace or repair dental structures, benefiting patients by restoring function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental ceramic material for porcelain-fused-to-metal restorations. Compatible with normal-fusing-temperature dental ceramic alloys. Formulated for laboratory baking/firing processes.

Indications for Use

Indicated for use in the fabrication of porcelain-fused-to-metal elements for fixed or removable dental prostheses. Intended for use by dental lab technicians under dentist direction; final placement in patient mouth performed by dentist.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road P.O. Box 799 Durham, New Hampshire 03824-0799

K982129 Re : Trade Name: Antagon Porcelain Regulatory Class: II Product Code: EIH Dated: June 17, 1998 Received: June 17, 1998

Dear Mr. Everngam:

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 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obligation you might have under sections 531

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Page 2 - Mr. Everngam

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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"(21CFR 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/dsma/dsmamain.html".

Sincerely yours,

S. Autman for

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

Enclosure

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510(k) Premarket Notification for Antagon Dental Porcelain. Submitted by european dental imports, inc., Reg#1218814

INDICATIONS FOR USE:

510(K) Number: K982129

Device Name: Antagon Porcelain

Indications for Use:

Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.

Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.

After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

Susan Runns

OR

Division of Dental. Infection Control.