CEREC 2 CROWN SOFTWARE

K972276 · Siemens AG · ELW · Aug 15, 1997 · Dental

Device Facts

• Record ID: K972276
• Device Name: CEREC 2 CROWN SOFTWARE
• Applicant: Siemens AG
• Product Code: ELW · Dental
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.

Device Story

Cerec 2 Crown Software functions as an extension to the Cerec 2 Dicor Dental Restoration System. Device utilizes 3D camera to capture optical impressions of dental preparations. Software processes these inputs to facilitate computer-aided design (CAD) and milling of ceramic dental restorations. Used in clinical dental settings by practitioners to produce inlays, veneers, partial crowns, and full crowns. Output enables fabrication of custom ceramic prosthetics, improving efficiency of restorative dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based CAD/CAM system for dental restoration design. Operates via 3D optical camera input. Connectivity involves integration with milling hardware. System is a modification of existing Cerec 2 software architecture.

Indications for Use

Indicated for dental patients requiring ceramic restorations, including inlays, veneers, partial crowns, and full crowns, via computer-aided design and milling.

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).

Predicate Devices

• Cerec 2 Dicor Dental Restoration System (K972276)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven A. Clarke, RAC Staff Consultant Siemens AG C/O Medical Device Consultants, Incorporated 49 Plain Street 02760 North Attleboro, Massachusetts

AUG 1 5 1997

Re: K972276 Cerac 2 Crown Software Trade Name: Requlatory Class: II Product Code: ELW Dated: June 17, 1997 Received: June 18, 1997

Dear Mr. Clarke:

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 Regulations, Title 21, Parts 800 to 895. ਬ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Clarke

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 Ulatowski

Timothy 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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510(k) Number (if known): _ K972276

Device Name: Cercc 2 Crown Software

Indications For Use:

The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susar Runver

(Division Sign-Off)

Division of Dontal, Infection Control. and General Hospital Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use No

Cerec 2 Crown Software 510(k)

June 17, 1997

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