(11 days)
Not Found
Not Found
No
The summary describes a coating medium for optical impressions and does not mention any AI or ML capabilities.
No
Explanation: The device is indicated as a coating medium for optical impressions, aiding in topographical recordings, which is a diagnostic or imaging aid, not a therapeutic intervention.
No
The "Intended Use / Indications for Use" states that the device is "a coating medium for optical impressions... It aids in intraoral topographical recordings". This describes a material used to assist in imaging, not a device that processes or interprets data to diagnose a condition.
No
The description explicitly states the device is a "coating medium" (CEREC Opti Spray), which is a physical substance, not software.
Based on the provided information, the CEREC Opti Spray is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in intraoral topographical recordings for optical impressions with the CEREC system. This is a process performed on the patient's body (intraoral) to capture the physical shape of teeth and surrounding structures.
- IVD Definition: In vitro diagnostics are tests performed outside of the body on samples such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The CEREC Opti Spray is a coating medium used to improve the quality of optical impressions taken directly from the patient's mouth. It's a tool used in a diagnostic imaging process, not a diagnostic test performed on a biological sample.
N/A
Intended Use / 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.
Product codes
ELW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
optical impressions
Anatomical Site
intraoral topographical recordings of prepared and unprepared teeth and their surrounding
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the perimeter and a stylized emblem in the center. The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and wings.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
2
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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