CEREC OPTI SPRAY

K080882 · Sirona Dental Systems GmbH · ELW · Apr 11, 2008 · Dental

Device Facts

• Record ID: K080882
• Device Name: CEREC OPTI SPRAY
• Applicant: Sirona Dental Systems GmbH
• Product Code: ELW · Dental
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

CEREC Opti Spray is indicated as a coating medium for optical impressions with the CEREC system. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surrounding.

Device Story

CEREC Opti Spray is a coating medium applied to teeth to facilitate optical impressions. It functions as a contrast agent to improve the accuracy of intraoral topographical recordings captured by the CEREC system. Used by dental professionals in a clinical setting, the spray is applied to prepared or unprepared teeth and surrounding tissues prior to scanning. The coating enhances the surface properties for optical capture, enabling the CEREC system to generate precise 3D digital models of the dentition. This process supports the fabrication of dental restorations by providing high-quality input data for the CEREC CAD/CAM workflow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Coating medium for optical impression systems. Formulated for intraoral application to provide surface contrast for optical scanning. Non-mechanical, non-electronic, chemical-based auxiliary device.

Indications for Use

Indicated for use as a coating medium to facilitate optical impressions of prepared and unprepared teeth and surrounding structures within the oral cavity using the CEREC system.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sirona Dental Systems GmbH C/O Mr. Stefan Preiss Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

APR 1 1 2008

Re: K080882

Trade/Device Name: CEREC Opti Spray Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 28, 2008 Received: March 31, 2008

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Preiss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Estate L. Michau Dmd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

CEREC Opti Spray is indicated as a coating medium for optical impressions with the CEREC system. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surrounding.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080882

Sirona Dental Systems 510(k) CEREC Opti Spray

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