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K Number
K971898
Device Name
PERMALUTE, TRY-IN PASTE
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
1997-06-24

(33 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Permalute try-In Pastes are color matching shades for use prior to placing Permalute Composite/Restorative Luting Resin. Permalute Try-In Pastes facilitate a close approximation of the final bonded outcome but in a water soluble reversible manner.

Device Description

Permalute Try-In Paste

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a product called "Permalute Try-In Paste." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter explicitly states that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This means the FDA did not require a new clinical study to establish safety and effectiveness, but rather relied on the established safety and effectiveness of similar products already on the market.

Therefore, I cannot provide the requested information, which would typically be found in a performance study report or clinical trial summary.

Here's why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: Not present in this document. Substantial equivalence determinations typically do not include specific performance criteria for the new device beyond demonstrating similarity to predicate devices.
  2. Sample sizes used for the test set and the data provenance: No test set or study data is presented.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set data is presented.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

This document is a regulatory approval based on "substantial equivalence," not a performance study report.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.