(50 days)
Trionomer is a resin reinforced glass ionomer cementation system used for the following:
- Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings;
- Luting metal inlays, onlays or crowns; .
- Luting pre-fabricated and cast posts; ●
- Luting orthodontic appliances; .
- Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations . recommending using conventional cements;
- . Cavity liners;
- Primary teeth cavity fillings; .
- Non-stress bearing restorations such as class V fillings. ●
Trionomer is a resin reinforced glass ionomer cementation system.
This is a 510(k) premarket notification for a dental cement (Trionomer). The provided document does not contain the kind of detailed study information (acceptance criteria, performance measurements, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a clinical study report for an AI/ML medical device.
The FDA 510(k) pathway for dental cements primarily relies on demonstrating substantial equivalence to a predicate device, often through a combination of material testing, performance testing (e.g., bond strength, fluoride release), and biocompatibility assessments, rather than human-reader studies or complex AI model validation.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is an FDA clearance letter and an indication for use statement; it does not detail the technical studies or their results.
§ 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.