(91 days)
TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Foremost Dental Mfg, Incorporated regarding their device, TempoCem. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.
However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence.
- Regulatory classification of the device (Class II).
- General controls provisions of the Act that apply to the device.
- Instructions for the manufacturer regarding labeling and promotion inquiries.
- Indications for use for TempoCem (temporary cementation of provisional crowns and bridges).
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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.