(90 days)
Cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm
Not Found
This is an FDA communication regarding a 510(k) premarket notification for a dental product, the BeautiCem Veneer Kit. It is not a study document describing acceptance criteria or device performance. Therefore, I cannot extract the requested information from the provided text.
The document states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for clearance, but the document does not provide details of specific performance criteria or a study that tested those criteria.
To elaborate on why the requested information cannot be found:
- Acceptance Criteria and Reported Device Performance: This document does not contain a table of acceptance criteria or the performance metrics of the BeautiCem Veneer Kit. It confirms the regulatory clearance based on substantial equivalence.
- Sample size and Data Provenance: Information regarding sample sizes for test sets, training sets, or data provenance (country, retrospective/prospective) is not present.
- Expert Details and Ground Truth Establishment: There is no mention of experts, their qualifications, or how ground truth was established for any studies.
- Adjudication Method: Adjudication methods are not discussed.
- MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or effect sizes of human readers with/without AI assistance, as this device is a dental material, not an AI diagnostic tool.
- Standalone Performance: As above, this is not an AI algorithm, so standalone performance is not relevant.
- Type of Ground Truth: The concept of "ground truth" (e.g., pathology, outcomes data) is typically associated with diagnostic or AI performance studies, which are not described here.
- Sample Size for Training Set: Not applicable, as this is a dental material.
- Ground Truth for Training Set: Not applicable.
This document is a regulatory approval letter, not a scientific study report.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Shofu Dental Corporation Mauro Malzyner Regulatory Affairs and Official Correspondent 1225 Stone Drive San Marcos, California 92078
Re: K180649
Trade/Device Name: BeautiCem Veneer Kit Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, KLE, EMA Dated: March 12, 2018 Received: March 13, 2018
Dear Mauro Malzyner:
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.
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 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);
June 11, 2018
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Mary S. Runner -5
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K180649
Device Name BeautiCem Veneer Kit
Indications for Use (Describe)
Cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------------------------- |
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§ 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.