EXCELSIOR PORCELAIN SYSTEM

K984427 · Ney Dental, Inc. · EIH · Mar 15, 1999 · Dental

Device Facts

• Record ID: K984427
• Device Name: EXCELSIOR PORCELAIN SYSTEM
• Applicant: Ney Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

USED IN THE MANUFACTURE OF PORCELAIN-FUSED-TO-METAL RESTORATIONS.

Device Story

Excelsior Porcelain System is a dental material used by dental laboratory technicians to create porcelain-fused-to-metal restorations. The system consists of porcelain powders applied to metal substructures to restore tooth form and function. The device is used in a dental laboratory setting. The final restoration is placed by a dentist to benefit patients requiring dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental porcelain system for porcelain-fused-to-metal restorations. Material composition and physical properties are consistent with standard dental porcelain materials used in restorative dentistry.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 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

K984427 Re : Excelsior Porcelain System Trade Name: Requlatory Class: II Product Code: EIH February 10, 1999 Dated: February 22, 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 Regulations, Title 21, Parts 800 to 895. ਜ 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 Reqister. 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 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 one regaration" (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

Tim A 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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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------------------|--------------------------------------------------------|--------------------------|
| (Division Sign-Off) | | |
| Division of Dental, Infection Control, and General Hospital Devices | | |
| 510(k) Number | K984427 | |
| | PLY | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |