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K Number
K011798
Device Name
CORERESTORE 2
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2001-08-14

(67 days)

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

Corerestore 2 is a fluoride releasing, resin-based material designed to be used for composite core build-ups. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration.

Device Description

Corerestore 2 is a fluoride released core build-up material. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration. The product is available in both, high and low viscosities.

AI/ML Overview

This document is a 510(k) summary for Corerestore 2, a dental composite core build-up material. It does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document primarily focuses on:

  • Device Identification: Trade name (Corerestore 2), common name (Composite Core Build-up Material), and classification name (Tooth shade resin material).
  • Substantial Equivalence: Claiming substantial equivalence to Jeneric/Pentron, Inc.'s Build-It and Kuraray Co., Ltd.'s Clearfil Photo Core.
  • Intended Use: For composite core build-ups.
  • Device Description: Fluoride-releasing material, dual-cure or light-cure configurations, available in high and low viscosities.
  • FDA Clearance Letter: Confirmation of 510(k) clearance (K011798) based on substantial equivalence.
  • Indications for Use Statement: Reiterating the device's intended use.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria and study details because the provided text does not contain this information.

§ 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.