SYMBIOCERAM

K990629 · Ney Dental, Inc. · EIH · Mar 19, 1999 · Dental

Device Facts

• Record ID: K990629
• Device Name: SYMBIOCERAM
• Applicant: Ney Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION.

Device Story

SYMBIOceram is a dental porcelain material used by dental laboratory technicians to fabricate porcelain-fused-to-metal (PFM) restorations. The material is applied to metal substructures to create crowns or bridges. It functions as a restorative dental material to replace missing tooth structure or improve aesthetics. The device is used in a dental laboratory setting. The final restoration is placed by a dentist to restore patient oral function and aesthetics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental porcelain material for porcelain-fused-to-metal restorations. No specific material standards, energy sources, or software components described.

Indications for Use

Indicated for use in the manufacture of porcelain-fused-to-metal 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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Mr. Andrew J. Pietrobono Manufacturing Engineer, Quality Manager, and Official Correspondent Ney Dental, Incorporated Porcelain Division 1065 S.W. 30th Avenue Deerfield Beach, Florida 33442-8193

K990629 Re : Trade Name: SYMBIOceram Regulatory Class: II Product Code: EIH February 17, 1999 Dated: February 26, 1999 Received:

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, Drug, 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) 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 regulation 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

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Page 2 - Mr. Pietrobono

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 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 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 (800) 638f2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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) Number (if known): | K990629 |
|---------------------------|-----------------------------------------------------------------------------------------------------|
| Device Name: | EXCELSTONE PORCELAIN<br>SYMBIOCERAM |
| Indications For Use: | DENTAL PORCELAIN DESIGNED FOR USE<br>IN THE MANUFACTURE OF PORCELAIN FUSED<br>TO METAL RESTORATION. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

susgin unto (Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices chacles 510(k) Number .

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

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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