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K Number
K992909
Device Name
HYTAC
Manufacturer
ESPE DENTAL AG
Date Cleared
1999-11-24

(86 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

Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings

Device Description

HYTAC® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.

AI/ML Overview

The provided text is a 510(k) summary for a dental filling material called HYTAC®. It describes the device, the context for its re-submission to the FDA, and its indications for use. However, it does not include information on acceptance criteria, a study proving the device meets those criteria, or any details related to AI or algorithm performance. The document focuses on the regulatory aspects of changing the indications for use of an already cleared dental product.

Therefore, I cannot fulfill your request for information related to AI acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth as these concepts are not present in the provided text.

The text indicates:

  • Device Name: HYTAC®
  • Classification Name: Tooth shade resin material
  • Common Name: Compomer filling material
  • Intended Use: To restore carious lesions or structural defects in teeth.
  • Expanded Indications: Class I, III, and V fillings, wedge-shaped defects, and Class II semipermanent fillings (up to two years). Previously limited to non-occlusal loaded fillings.

The change in indications for use was based on "good clinical experience, laboratory test data and comparison to DYRACT® AP by a study," but the specifics of that study (like acceptance criteria, sample size, etc.) are not detailed in this summary.

§ 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.