(75 days)
Grandio Core Dual Cure:
- core build ups of vital and non-vital teeth
- Luting of root posts
Not Found
The provided text is an FDA 510(k) clearance letter for a dental device called "Grandio Core Dual Cure." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, clinical study design, or performance metrics.
Therefore, I cannot extract the requested information regarding:
- Acceptance Criteria and Reported Device Performance: This information is not present.
- Sample size used for the test set and data provenance: No test set or study data is described.
- Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
- Adjudication method for the test set: Not applicable as no test set is described.
- Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only without human-in-the-loop performance): This is a dental material, not an AI algorithm.
- Type of ground truth used: Not applicable as no study is described.
- Sample size for the training set: Not applicable as no training set for an AI algorithm is involved.
- How the ground truth for the training set was established: Not applicable.
The document discusses the regulatory review of a dental material's "substantial equivalence" to legally marketed predicate devices, based on its indications for use. It's a regulatory clearance, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 8 2011
Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY
Re: K112447
Trade/Device Name: Grandio Core Dual Cure Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 22, 2011 Received: August 25, 2011
Dear Dr. Gerkensmeier:
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. In addition, FDA may publish further announcements concerning your device in the Federal Register.
DEPARTMENT OF HEALTH & HUMAN
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Page 2 - Dr. Gerkensmeier
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.
hh 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 Statement
| 510(k) Number: | K112447 |
|---|---|
| Device Name: | Grandio Core Dual Cure |
| Indications for Use: |
Grandio Core Dual Cure:
- core build ups of vital and non-vital teeth
- Luting of root posts
| Prescription Use X | OR | Over-The-Counter Use |
|---|---|---|
| ---------------------- | ---- | ---------------------- |
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: ] | | | 2447
§ 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.