LogoFDA 510(k) Search
K Number
K062515
Device Name
RETENTION FLOW OPAQUE
Manufacturer
HERAEUS KULZER GMBH
Date Cleared
2006-11-22

(86 days)

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

Retention Flow Opaque is a light curing, transparent component for filling undercut areas in retentions.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the requested information. The document is an FDA 510(k) clearance letter for a dental device called "Retention Flow Opaque." It confirms the device's substantial equivalence to a predicate device but does not contain any details about:

  • Acceptance criteria or reported device performance metrics.
  • Specific studies (e.g., test set sample size, data provenance).
  • Ground truth establishment details (number of experts, qualifications, adjudication method, type of ground truth).
  • Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
  • Training set details (sample size or ground truth establishment).

The letter primarily focuses on regulatory approval and compliance.

§ 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.