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K Number
K182780
Device Name
XP Composite
Manufacturer
S&C Polymer Silicon- und Composite Spezialitaeten GmbH
Date Cleared
2019-07-03

(275 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K042819
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Restoration of deciduous teeth
  • Posterior restorations (class I and II)
  • Anterior restorations (class III and IV)
  • Class V restorations
  • Veneering of discoloured anterior teeth
  • Splinting of mobile teeth
  • Extended fissure sealing in molars and premolars
  • Repair of composite and ceramic veneers
Device Description

"XP Composite" is a light cure composite.

AI/ML Overview

The provided text is a 510(k) Summary for a dental restorative material, "XP Composite." It describes the device, its intended use, and its substantial equivalence to a predicate device, Tetric EvoCeram. This document does NOT contain information about an AI/ML-based medical device study, nor does it provide details about acceptance criteria and performance data in the context of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size
  6. If a standalone (algorithm only) performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document focuses on the physical and chemical characteristics, intended use, and non-clinical performance data (e.g., compressive strength, water sorption) of a dental composite material to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission. It's a traditional medical device clearance, not an AI/ML device.

§ 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.