FINESSE ALL-CERAMIC SYSTEM

K971869 · Dentsply Intl. · EIH · Sep 11, 1997 · Dental

Device Facts

• Record ID: K971869
• Device Name: FINESSE ALL-CERAMIC SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EIH · Dental
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The FINESSE™ ALL-CERAMIC SYSTEM is used only with Finesse™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.

Device Story

The Finesse™ All-Ceramic System is a glass-ceramic material for dental restorations. The process involves placing glass material into a heat and pressure deformable crucible; heating to working temperature; injecting molten glass into a mold containing a preformed dental restorative cavity; cooling; and removing the glass coping. The coping is heat-treated to crystallize into a glass-ceramic. Finesse™ Low-Fusing Porcelain is applied to the coping to complete the restoration. The device is used in a dental laboratory setting by technicians to create restorations for patients. The final restoration provides aesthetic benefits, wear characteristics, and polishability. It is intended for inlays, onlays, veneers, anterior crowns, and selected posterior crowns.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including biocompatibility studies (MEM Elution, Ames Mutagenicity, and Hamster Cheek Pouch Irritation).

Technological Characteristics

Glass-ceramic material system. Components previously used in predicate medical devices. Evaluated for biocompatibility via MEM Elution, Ames Mutagenicity, and Hamster Cheek Pouch Irritation studies.

Indications for Use

Indicated for the fabrication of dental restorations including inlays, onlays, veneers, complete crowns on anterior teeth, and single crowns on selected posterior teeth, when used in conjunction with Finesse™ Low-Fusing Porcelain.

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.

Predicate Devices

• DICOR® Castable Ceramic (K830955A)

Submission Summary (Full Text)

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# 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

#### DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 171 845-7511 P. J. Lehn Tele

CONTACT: P. Jeffery Lehn

May 19, 1997 DATE PREPARED:

TRADE OR PROPRIETARY NAME: FINESSE™ ALL-CERAMIC SYSTEM

872.6660 CLASSIFICATION NAME: Porcelain Powder for Clinical Use

K830955A DICOR® Castable Ceramic PREDICATE DEVICE:

DEVICE DESCRIPTION: The FINESSE™ALL-CERAMIC SYSTEM is a glass-ceramic material designed to be used with Finesse™ Low-Fusing Porcelain. By combining the core material with the Finesse™ Low-Fusing Porcelain, the laboratory can offer the recognized aesthetics wear characteristic and chair-side polishability of Finesse™ Low-Fusing Porcelains combined with the aesthetic benefits of an all-ceramic system.

A dental restoration is prepared by placing a glass material in a heat and pressure deformable crucible. Heat is applied to the crucible to bring the glass to a "working" temperature. The glass is brought into contact with a mold having a preformed dental restorative cavity. The crucible is crushed and the molten glass is then injected into the mold. After cooling, the glass coping is removed from the mold. The glass restoration is heat treated to crystallize into a glass-ceramic. Finesse™ Low-Fusing Porcelain is then applied on the glass-ceramic coping to complete the restoration.

INTENDED USE: The FINESSE™ ALL-CERAMIC SYSTEM is used only with Finesse™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.

TECHNOLOGICAL CHARACTERISTICS: All components in the FINESSE™ ALL-CERAMIC SYSTEM have been used in predicale medical devices or have been found safe for dental use.

The FINESSE™ ALL-CERAMIC SYSTEM has been evaluated by the MEM Elution Test and found to be non-cytotoxic, by the Ames Mutagenicity Assay and found to be non-mutagenic, and by the Hamster Cheek Pouch Irritation Study (mucous membrane) and found to be a non-irritant.

We believe that the prior use of the components in predicate devices, the results of the toxicity and irritation testing, and the performance data support the safety and effectiveness of the FINESSE™ ALL-CERAMIC SYSTEM for the intended uses.

000001
JUL 2 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### SEP | | 1997

Mr. P. Jeffrey Lehn Director, Corporate Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

K971869 Re : Finesse™ All-Ceramic System Trade Name: Regulatory Class: II Product Code: ETH Dated: July 24, 1997 Received: July 25, 1997

Dear Mr. Lehn:

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 reqistration, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation 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 obliqation you might have under sections 531

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Page 2 - Mr. Lehn

through 542 of the Act for devices under the Electronic enrough Siz of on 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 requlation entitled, "Misbranding by reference to one arket 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

Tim 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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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K971869

Device Name:

FINESSE™ALL-CERAMIC SYSTEM

Indications for Use:

Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.

Susan Runver

(Division Sign Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Dental Infection Control,
and Gereral Hospital De aces
K971869

5. Prescription Use Yes
OR
Over-The-Counter Use No