CEREC 3

K994172 · Sirona Dental Systems GmbH · ELW · Feb 8, 2000 · Dental

Device Facts

• Record ID: K994172
• Device Name: CEREC 3
• Applicant: Sirona Dental Systems GmbH
• Product Code: ELW · Dental
• Decision Date: Feb 8, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.

Device Story

CEREC® 3 is a computer-aided design (CAD) and milling system for dental restorations. Used in dental clinics by dentists; system captures dental anatomy data; software designs restoration; integrated milling unit fabricates ceramic inlays, onlays, veneers, partial crowns, and full crowns. Enables chairside production of restorations; eliminates need for temporary restorations or multiple patient visits; improves clinical efficiency and patient convenience.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

CAD/CAM system; includes optical scanning/imaging, computer-aided design software, and automated milling unit. Designed for chairside fabrication of ceramic dental restorations. Operates via digital input and mechanical subtractive manufacturing.

Indications for Use

Indicated for patients requiring ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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Public Health Service

8 2000 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sirona Dental Systems, GmbH c/o Ms. Sheila Hemeon-Heyer Sirona Dental Systems, GmbH MDCI Consultants 49 Plain Street North Attleboro, Massachusetts

Re : K994172

> CEREC® 3 Ceramic Dental Restoration System Trade Name: Requlatory Class: II Product Code: ELW Dated: January 7, 2000 Received: January 10, 2000

Dear Ms. Hemeon-Heyer:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Ms. Hemeon-Heyer

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.

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 [phone] 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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## K994172 510(k) Number (if known):

Device Name: CEREC® 3 CERAMIC DENTAL RESTORATION SYSTEM

Indications For Use:

The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Beadle W. Shipp

(Division Sign-Off) Consion of Dental, Infection Control, oneral Hospital Devices traber _ ાર વેવ

> Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Sirona Dental Systems GmbH Special 510(k) CEREC® 3 Ceramic Dental Restoration System 12/09/99

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