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K Number
K974494
Device Name
RENAMEL FLOWABLE COMPOSITE
Manufacturer
COSMEDENT, INC.
Date Cleared
1998-02-10

(74 days)

Product Code
EBD
Regulation Number
872.3310
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.

Device Description

Renamel Flowable Composite is a system consisting of light-cured flowable composite restorative dental materials.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance for the "Renamel Flowable Composite" device.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It covers:

  • Device Name: Renamel Flowable Composite
  • Manufacturer: Cosmedent, Incorporated
  • Regulatory Class: II
  • Product Code: EBD
  • Date of Clearance: February 10, 1998
  • Indications for Use: Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.
  • Device Description: A system consisting of light-cured flowable composite restorative dental materials. It also mentions a "confidential chemical analysis... in Appendix C," which is not provided.

However, the letter does not include:

  • Specific acceptance criteria for performance.
  • Details of any study (like sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).
  • Any performance metrics or results.

For a 510(k) submission, the primary aim is to demonstrate substantial equivalence to a predicate device, not necessarily to conduct de novo clinical trials with strict performance criteria and detailed study designs as might be found in a PMA (Premarket Approval) application or a more recent clinical study report. The FDA concluded that the device is substantially equivalent, implying that its performance characteristics are comparable to existing, legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions about study design, sample sizes, expert involvement, or reported performance.

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.