(67 days)
Core build-up of vital and non-vital teeth
Not Found
The provided text is a 510(k) Pre-Market Notification letter from the FDA regarding a dental device called "Rebilda DC." This document primarily focuses on classifying the device and determining its substantial equivalence to predicate devices, rather than detailing a specific study proving the device meets acceptance criteria.
Therefore, the information requested in the prompt based on a study of the device's performance is largely not present in the provided text. The document is an administrative letter of approval, not a scientific study report.
However, I can extract the following limited information:
- Trade/Device Name: Rebilda® DC
- Regulation Name: Tooth Shade Resin Material
- Regulatory Class: II
- Product Code: EBF
- Indications for Use: Core build-up of vital and non-vital teeth
Regarding the specific questions in the prompt:
- A table of acceptance criteria and the reported device performance: This information is not available in the provided FDA letter. The letter confirms substantial equivalence, which implies the device meets certain performance standards comparable to existing devices, but it does not detail specific acceptance criteria or reported performance data.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This is a dental material, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. As mentioned, this is a dental material.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
In summary, the provided FDA letter confirms the substantial equivalence of the Rebilda DC device to predicate devices for its intended use, allowing it to be marketed. However, it does not contain the detailed study results, acceptance criteria, or performance data typically found in a scientific or clinical study report.
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MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VOCO GmbH C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K030914
Trade/Device Name: Rebilda® DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 22, 2003 Received: March 24, 2003
Dear Mr. Shipps:
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. Gerald W. Shipps
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Pompeo
Susan Runner, DDS, MA Interim 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
<030914 510(k) Number:
Device Name: Rebilda DC
Indications for Use:
Core build-up of vital and non-vital teeth
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___________
OR
Over-The-Counter Use _ _ _ _
Robert Sbeh DDS for Dr. K. Mulay
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K030914
§ 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.