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K Number
K240714
Device Name
Insure® Universal; Insure® Universal Automix
Manufacturer
Cosmedent Inc.
Date Cleared
2024-07-24

(131 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Insure® Universal
Cementation of ceramic and composite veneers, inlays and onlays with a thickness

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental cement product (Insure® Universal; Insure® Universal Automix).

This letter primarily focuses on:

  • Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Information: Details about regulations (e.g., 21 CFR 872.3275 for Dental Cement, Quality System regulation 21 CFR Part 820), responsibilities of the manufacturer (listing, labeling, adverse event reporting, good manufacturing practices), and guidance documents.
  • Indications for Use: What the dental cement is intended to be used for (e.g., cementation of ceramic and composite veneers, inlays, onlays, crowns, and bridges).

There is no mention of specific performance metrics, acceptance criteria tables, study designs (sample sizes, retrospective/prospective, number of experts, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for any AI or software-related device. The product mentioned is a physical dental cement, not an AI software or a device that would typically involve the types of studies you are asking about (like imaging devices with AI assistance).

Therefore, I cannot fulfill your request based on the provided 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.