(60 days)
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
- Luting resin crowns, bridges, inlays, onlays and veneers;
- Luting metal or non-metal/fiber posts;
- Luting orthodontic appliances;
- Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
BisCem is a dual-cured self etching and self adhesive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system, BisCem can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly. It is intended for use as a luting cement.
The provided text describes a dental luting cement called BisCem and its 510(k) submission. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics or clinical study results.
The document primarily focuses on establishing substantial equivalence to a predicate device (BisCem GI) based on intended use, chemical composition, and physical properties. It also confirms biocompatibility.
Therefore, I cannot fulfill your request for the tables and information related to acceptance criteria and performance studies because the input text does not provide this data.
Here's a breakdown of the requested information and why it's not present in the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document compares features of BisCem to BisCem GI but doesn't list specific performance metrics with acceptance criteria or study results for BisCem.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This type of study is entirely irrelevant for a dental luting cement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This is also not relevant for a dental cement.
- The type of ground truth used: Not mentioned (and not applicable for this type of device submission).
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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.