(304 days)
TotalCem
The device is intended for the cementation of posts, crowns, bridges, inlays and onlays.
DentoCem
The device is intended for permanent cementation of:
- crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers;
- . implant prosthesis:
- orthodontic attachments:
- amalgam restorations:
- veneering of alloys: and ●
- composite restorations. .
TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components.
The provided text is a 510(k) summary for dental cements (TotalCem and DentoCem). It details the device's technical characteristics, intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in reports for AI/ML-driven medical devices.
Instead, the documentation focuses on demonstrating substantial equivalence based on:
- Indications for Use: Comparing the intended uses of TotalCem and DentoCem with their respective predicate devices.
- Technological Characteristics: Comparing the matrix, fillers, delivery method, curing method, and radiopacity of the subject devices with their predicates.
- Biocompatibility Testing: Mentioned as being combined with the above comparisons to draw conclusions.
- Conformity with Guidance Documents and Standards: Reference to "FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998" and "ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials."
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided 510(k) summary.
The document concludes that "the subject devices have been shown to be safe and effective for their intended use" and "substantially equivalent to their respective predicates" based on the comparisons outlined above and biocompatibility testing. This is a common approach for conventional medical devices demonstrating substantial equivalence, rather than providing detailed performance metrics against pre-defined acceptance criteria through a specific clinical study as might be expected for an AI-powered device.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.