(4 days)
- Temporary cementation of provisional restorations
- Temporary cementation of final restorations
3M™ Protemp™ Cement Temporary Dental Cement is a radiopaque, temporary cement used for temporary or provisional fixation of dental restorations. It is a selfcuring cement, with an option for tack light curing of any excess cement for ease of clean up. As a non-eugenol cement, Protemp™ Cement Temporary Dental Cement is suitable for use on patients with sensitivity to eugenol. Protemp™ Cement Temporary Dental Cement consists of a base and catalyst paste packaged in a proprietary automix delivery dispenser with a self-sealing cap. The automix delivery dispenser offers convenience over traditional hand mixed cements. Compared to leading automix systems, the proprietary delivery dispenser is designed to generate less waste and also has a lower extrusion force for ease of use. It is available in two shades. Opaque and Translucent.
The provided document is a 510(k) summary for a dental cement (3M™ Protemp™ Cement Temporary Dental Cement) and does not describe an AI medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, expert involvement, or other details relevant to AI device performance evaluation.
The document discusses the substantial equivalence of the new dental cement to a predicate device (Temp-Bond™ NE) based on:
- Bench Testing: Evaluating properties such as working and setting times, bonding strength, film thickness, compressive strength, extrusion force, radiopacity, dimensional change, and fluoride release profile.
- Biocompatibility Testing: Assessed according to ISO standards like ISO 10993 and ISO 7405.
Since the request pertains to an AI device and the provided document is not for an AI device, I cannot fulfill the request as specified.
§ 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.