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K Number
K113040
Device Name
CERAMIR CROWN & BRIDGE
Manufacturer
DOXA DENTAL AB
Date Cleared
2011-12-28

(77 days)

Product Code
EMA
Regulation Number
872.3275
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ceramir Crown & Bridge is intended for the permanent cementation of

  • Metal and Porcelain Fused to Metal Crowns and Bridges .
  • Gold inlays and onlays .
  • Cast or prefabricated metal posts .
  • Cast of prefabriodical metally provins and bridges suitable for conventional ● righ Strength og. zirconia, alumina, and lithium disilicate)
Device Description

Not Found

AI/ML Overview

This looks like an FDA 510(k) clearance letter for a dental cement. The provided text does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot generate the requested table and study details.

The document discusses:

  • Device Name: Ceramir Crown & Bridge
  • Regulation Number/Name: 21 CFR 872.3275(b) Dental Ceramic
  • Product Codes: EMA
  • Intended Use: Permanent cementation of various dental restorations (metal, PFM crowns/bridges, gold inlays/onlays, metal posts, high-strength ceramic crowns/bridges).
  • Regulatory Clearance: 510(k) substantial equivalence determination.

To fulfill your request, I would need a document from Doxa Dental AB that details the specific performance studies conducted for Ceramir Crown & Bridge to demonstrate substantial equivalence, including the acceptance criteria and results.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.