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K Number
K012307
Device Name
LUXACORE/LUXACORE DUAL
Manufacturer
DMG USA, INC.
Date Cleared
2001-08-23

(31 days)

Product Code
EBF
Regulation Number
872.3690
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
K932826,K872510,K964000,K982201
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts.

LuxaCore and LuxaCore Dual can also be used for:

  • . Luting of abutments to dentures (LuxaCore)
  • . Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
  • . Repair material for provisionals
  • . Bite registration material.
  • . Build up material for plastic bite rails (occlusal individualisation).
  • . Cement for pins and posts
  • . Semipermanent restorative material (e.g., in childrens' teeth)
Device Description

LuxaCore: LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material.

LuxaCore Dual: LuxaCore Dual is a dual cure (chemical and/or light cure), radiopaque two-component core build-up material supplied in automix delivery systems or as a handmix material

AI/ML Overview

The provided text is a 510(k) Premarket Notification for dental materials (LuxaCore / LuxaCore Dual) and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of an AI/medical imaging device.

Specifically, the document:

  • Describes dental core build-up and restorative materials.
  • Identifies predicate devices for substantial equivalence.
  • Lists indications for use for the dental materials.
  • States it's an Abbreviated 510(k) and references conformity with FDA guidance for "Dental Composites - Premarket Notification."
  • Concludes the materials are "safe and effective for their intended use" based on technological characteristics and comparison to predicate devices.
  • Includes correspondence from the FDA confirming substantial equivalence.

There is no mention of:

  • Acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for an AI device.
  • Any study that tests an AI algorithm's performance against such criteria.
  • Sample sizes for test or training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or types of ground truth relevant to AI performance evaluation.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI device meets them based on the provided text.

§ 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.