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K Number
K051427
Device Name
GC FUJI FIL LC
Manufacturer
GC AMERICA, INC.
Date Cleared
2005-08-22

(82 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

This product is a radiopaque light-cured reinforced glass ionomer restorative for use in the following recommended indications:

  1. Class III and V restorations, particularly for cervical erosions and root surface caries.
  2. Restoration of primary teeth
  3. Core Build-up
  4. Cases where radiopacity is required
  5. As a base or a liner.
Device Description

GC Fuji Fil LC is a radiopaque light-cured reinforced glass ionomer restorative.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a dental cement (GC Fuji Fil LC), indicating it has been found substantially equivalent to a legally marketed predicate device.

The document includes:

  • Trade/Device Name: GC Fuji Fil LC
  • Regulation Number: 21 CFR 872.3275
  • Regulation Name: Dental Cement
  • Regulatory Class: II
  • Product Code: EMA
  • Indications for Use:
    1. Class III and V restorations, particularly for cervical erosions and root surface caries.
    2. Restoration of primary teeth
    3. Core Build-up
    4. Cases where radiopacity is required
    5. As a base or a liner.

However, it does not contain details regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader, multi-case (MRMC) comparative effectiveness study.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This kind of detailed study information is typically found in the 510(k) submission summary or the actual study reports, which are not part of this FDA 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.