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K Number
K042348
Device Name
GRADIA DIRECT LOFLO
Manufacturer
GC AMERICA, INC.
Date Cleared
2004-11-18

(80 days)

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

This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity undercuts. 7. Sealant. 8. Fixation of mobile teeth. 9. Additions to composite restorations.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative material, not a study report detailing acceptance criteria and performance data for a device involving AI or complex statistical analysis.

Therefore, the requested information elements (1 through 9) related to a study proving device meeting acceptance criteria, especially those pertinent to AI/software performance, are not present in this document.

Specifically, there is no information regarding:

  1. A table of acceptance criteria and the reported device performance: This letter indicates substantial equivalence to a predicate device, not a performance study against specific acceptance criteria.
  2. Sample size used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental material, not an AI-assisted diagnostic device.
  6. If a standalone performance (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 serves as an FDA clearance for a dental material (Gradia® Direct LoFlo) based on its substantial equivalence to previously marketed predicate devices, not on a new clinical performance study with detailed acceptance criteria and statistical analysis as would be relevant for devices with diagnostic or AI components.

§ 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.