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K Number
K112574
Device Name
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
Manufacturer
PRIME DENTAL MANUFACTURING, INC.
Date Cleared
2012-01-23

(139 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

The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.

Device Description

Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement.

AI/ML Overview

I am sorry, but I cannot fulfill your request to describe acceptance criteria and associated studies for the "Prime-Dent® Dual Cure Composite Luting Cement" based on the provided text.

Here's why:

The provided document is a 510(k) substantial equivalence letter from the FDA. This letter indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that those differences do not raise different questions of safety or effectiveness.

This type of FDA letter generally does not contain the detailed acceptance criteria and study results you are asking for. It's a regulatory notification, not a scientific publication or a technical report of device performance studies.

Specifically, the document does not contain any of the following information requested in your prompt:

  • A table of acceptance criteria and the reported device performance.
  • Sample size used for the test set and data provenance.
  • Number of experts used to establish ground truth and their qualifications.
  • Adjudication method.
  • MRMC comparative effectiveness study results or effect size.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The letter states the "Indications for Use" for the device, which describes what the cement is intended for (final cementation of crowns, bridges, etc.), but it doesn't provide performance metrics or studies to prove these indications.

To get the information you are looking for, you would typically need to consult a pre-market approval (PMA) application, a scientific publication, or the manufacturer's technical documentation, which are not found in this 510(k) clearance letter.

§ 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.