LogoFDA 510(k) Search
K Number
K982459
Device Name
TEMPFIL F - 2
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
1998-09-30

(77 days)

Product Code
EBG,EBU
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TempFil F - 2 is a light oured, single component temporary filling material intended l emplil F - Z is a light-successingle compensions in the go to be used for inlay and only preparations, implantserew-access openings andto be assurement of lost fillings for the emergency

Device Description

The device is a visible light-cured, single component temponery filling material. It is specifically designed for temporary inlays and onlays. TempFil F - 2 has a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental temporary restorative material called TempFil F-2. It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices, but it does not detail any specific performance studies or acceptance criteria that would allow me to fill out the requested table and answer your questions.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.