(85 days)
Used for bases, linings and to cement crowns and bridges.
It decreases post-operative sensitivity. Bonds to tooth structure.
Glass Ionomer cement called Desens-Ionomer
The provided document is a 510(k) clearance letter from the FDA for a dental cement called "Desens-Ionomer." This type of document does not contain the information requested in your prompt.
Specifically, a 510(k) clearance determines if a new medical device is "substantially equivalent" to an existing legally marketed device (predicate device). It does not typically require the extensive clinical study data, acceptance criteria, or performance metrics that would be found in a Premarket Approval (PMA) application or a detailed clinical study report for software, especially AI-driven medical devices.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the "Desens-Ionomer" beyond its stated indications for use (bases, linings, cementing crowns/bridges, decreasing post-operative sensitivity, bonding to tooth structure).
- Sample size used for the test set and data provenance: No clinical study details are provided.
- Number of experts used to establish ground truth and their qualifications: Not applicable to this type of regulatory document.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and unlikely for a dental cement 510(k).
- Standalone (algorithm only) performance: Not applicable as this is a physical dental cement.
- Type of ground truth used: No mention of ground truth as a clinical study is not detailed.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The letter confirms that the FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
§ 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.