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K Number
K982695
Device Name
GC RELINE
Manufacturer
GC AMERICA, INC.
Date Cleared
1998-10-19

(77 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GC Reline is an acrylic resin for direct denture linings and extension of denture borders.

Device Description

GC Reline is an acrylic resin for direct denture linings and extension of denture borders.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a device named "GC Reline." This type of document declares substantial equivalence to a predicate device and permits marketing, but it does not contain a detailed description of acceptance criteria or a study proving that the device meets those criteria.

The letter explicitly states:

  • "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
  • "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

Substantial equivalence (SE) means the new device is as safe and effective as a legally marketed predicate device, and it does not require clinical trials to demonstrate effectiveness and safety if existing data on the predicate device or a combination of bench and non-clinical testing can support this claim.

Therefore, I cannot provide the requested information because the provided document does not contain:

  1. A table of acceptance criteria or reported device performance.
  2. Information on sample sizes, data provenance, or details of a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study details.
  6. Standalone algorithm performance.
  7. Type of ground truth used in a study.
  8. Training set sample size.
  9. How training set ground truth was established.

The document is purely an administrative letter granting clearance based on the comparison to a predicate device, not a report of a study designed to meet specific performance acceptance criteria for a new, de novo device.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.