SUPER PORCELAIN ADDMATE

K983247 · Noritake Co., Inc. · EIH · Nov 3, 1998 · Dental

Device Facts

• Record ID: K983247
• Device Name: SUPER PORCELAIN ADDMATE
• Applicant: Noritake Co., Inc.
• Product Code: EIH · Dental
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .

Device Story

Super Porcelain Addmate is a dental material used by dental professionals in laboratory settings to fabricate porcelain prostheses. The material is applied to dental alloy frames to create restorative dental structures. It functions as a ceramic veneering material, enabling the construction of crowns, bridges, or other prosthetic appliances. The device benefits patients by providing a durable, aesthetic, and functional replacement for missing or damaged tooth structure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental porcelain material for prosthetic applications. Formulated for application onto dental alloy frameworks. Standard dental ceramic composition.

Indications for Use

Indicated for use in prosthetic dentistry for the creation of porcelain prostheses on dental alloy frames.

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOV

Noritake Company, Incorporated C/o Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re : K983247 Super Porcelain Addmate Trade Name: Requlatory Class: II Product Code: EIH September 16, 1998 Dated: September 16, 1998 Received:

Dear Ms. Wertzberger:

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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Wertzberger

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 leqally 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 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. Ulatowsk Directdr 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) Number (if known): K983247

SUPER PORCELAIN ADDMATE Device Name: __

Indications For Use:

FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .

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**General CORE Object Device Definition (CODD)**

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(Division Sign-Off) Division of Dontal, unfection Control, and General bospital I 510(k) Number ...

**Prescription Use**
**(Per 21 CFR 801.109)**

OR

**Over-The-Counter Use**

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(Optional Formal 1-2-96)

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02/13 '96 11:07