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K Number
K181312
Device Name
GrandioSO x-tra
Manufacturer
VOCO GmbH
Date Cleared
2018-08-22

(97 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Class I and II posterior restorations
  • Base in class I and II cavities
  • Class V restorations
  • Locking, splinting of loose teeth
  • Repairing veneers, enamel defects and temporary C&B-materials
  • Extended fissure sealing
  • Restoration of deciduous teeth
  • Core build-up
Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental resin material named "GrandioSO x-tra." It confirms the device's substantial equivalence to a predicate device for specific dental restoration indications.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment. These details are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the input 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.