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K Number
K982590
Device Name
TEMPBOND CLEAR-2
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
1998-10-08

(76 days)

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

TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.

Device Description

The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental cement called "TempBond Clear - 2", which includes general device information, its intended use, and substantial equivalence claim to another legally marketed device. It also includes an FDA letter confirming the device's substantial equivalence and allowing it to be marketed.

Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the given text.

§ 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.