LogoFDA 510(k) Search
K Number
K023888
Device Name
CIMOFLUOR
Manufacturer
GLOBAL DENTAL PRODUCTS, INC.
Date Cleared
2003-03-05

(104 days)

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

Intended for temporary root canal filling during endodontic therapy.

Device Description

CIMOFLUOR

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called CIMOFLUOR, which is a root canal filling resin. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of a clinical study or acceptance criteria.

Therefore, the document does not contain the information required to answer the questions about acceptance criteria and study details.

Specifically:

  1. A table of acceptance criteria and the reported device performance: Not provided.
  2. Sample size used for the test set and the data provenance: Not provided. The document refers to a "premarket notification" but does not detail the testing performed or the data provenance.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  5. 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 provided. The device is a root canal filling resin, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical product, not an algorithm.
  7. The type of ground truth used: Not provided.
  8. The sample size for the training set: Not applicable (not an AI device).
  9. How the ground truth for the training set was established: Not applicable (not an AI device).

§ 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.