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K Number
K123273
Device Name
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
Manufacturer
TEMREX CORP.
Date Cleared
2012-12-07

(49 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

Indications For Use: Hoffmann's cements (Phosphate- Normal, quick setting) is indicated for the temporary application of provisional crowns, bridges, inlay, and onlays. Luting/ lining cements.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental cement called "Hoffmann's Cement." It does not contain information about the acceptance criteria or a study that proves a device meets those criteria.

Therefore, I cannot provide the requested information. The document is strictly a regulatory approval notice for a medical device.

§ 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.