(95 days)
Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental filling material (Tetric EvoCeram Bulk Fill). It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document discusses:
- The FDA's determination of substantial equivalence for the dental material.
- Regulatory classifications and requirements for medical devices.
- Indications for use for the Tetric EvoCeram Bulk Fill material (restoration of deciduous teeth, posterior restorations (Classes I and II), Class V restorations, and extended fissure sealing).
In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and device performance evaluation for an AI/ML product.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 4 2011
Ms. Donna Marie Hartnett Director Quality Assurance/ Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K111958
Trade/Device Name: TETRIC EVOCERAM® BULK FILL Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 7, 2011 Received: July 18, 2011
Dear Ms. Hartnett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Inaddition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Hartnett
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ph for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K111958
Device Name: TERIC EVOCERAM® BULK FILL Indications For Use:
Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K111958 |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.