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K Number
K111685
Device Name
IP TEMP CEMENT
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2011-09-02

(78 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

IP Temp Cement, is temporary luting cement intended for temporary cementation of permanent restorations including crowns and bridges etc. or provisional restorations to natural teeth (intraoral hard tissue) or other materials (implant abutment etc.).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding "IP Temp Cement," a dental cement. It does not contain any information about acceptance criteria or a study demonstrating device performance in the context of an AI/algorithm-based medical device.

The letter explicitly states it's a determination of "substantial equivalence" to legally marketed predicate devices, not an evaluation of performance against specific acceptance criteria for a novel device, especially not an AI-powered one.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text. This letter pertains to a traditional dental material, not an AI or algorithm-based 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.