(75 days)
Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.
Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.
The provided text is a 510(k) submission for Steri-Oss' ImProv Temporary Dental Cement. In this type of submission, the manufacturer claims substantial equivalence to previously cleared predicate devices, rather than conducting new performance studies against specific acceptance criteria.
Specifically, the document states: "Performance Data: Not applicable". This means that the submission does not include primary data from a study designed to meet specific acceptance criteria for the device's performance. Instead, substantial equivalence is claimed based on similar technological characteristics (e.g., curing type, system, cement base) to the predicate devices.
Therefore, I cannot provide the requested information for the following points as no such study or acceptance criteria are described in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.