(77 days)
MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries:
IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlavs/onlays with extra-oral post tempering
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product, MICROHYBRID 12. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory classifications and requirements.
- Indications for use and contraindications for the dental filling material.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness study results, as this information is not present in the provided text.
§ 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.