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K Number
K030646
Device Name
BELLEGLASS POINT 4
Manufacturer
KERR DENTAL MATERIALS CENTER
Date Cleared
2003-05-06

(67 days)

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

belleGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.

Device Description

belieGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.

AI/ML Overview

This document is a 510(k) summary for a dental restorative material, belleGlass Point 4. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot provide the requested information. The document does not describe:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods.
  • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used, sample size for the training set, or how ground truth for the training set was established.

This document is a regulatory submission for premarket notification, not a clinical or performance study report. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving its performance against specific acceptance criteria for a novel functionality.

§ 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.