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K Number
K143212
Device Name
Bifix Temp
Manufacturer
VOCO GMBH
Date Cleared
2015-05-01

(172 days)

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

Bifix Temp is intended for use as:

  • Non-permanent luting of temporary restorations.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a letter from the FDA regarding a 510(k) premarket notification for a dental cement product, Bifix Temp. It primarily discusses the substantial equivalence determination and regulatory requirements, not performance studies or acceptance criteria.

§ 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.