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K Number
K022797
Device Name
TWINKY STAR
Manufacturer
VOCO GMBH
Date Cleared
2002-10-10

(48 days)

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

Twinky Star is a compomer filling material for deciduous teeth.

Device Description

Not Found

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for a dental filling material called "Twinky Star." This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models. It discusses the device's classification, applicable regulations, and approval for marketing based on substantial equivalence to a predicate device.

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

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or details of a test set.
  3. The number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes of AI assistance.
  6. Standalone algorithm performance.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.