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K Number
K050013
Device Name
RETRACTOFOAM
Manufacturer
COLTENE/WHALEDENT AG
Date Cleared
2005-02-09

(37 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the temporary opening/widening of the sulcus.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details for the RetractoFoam device.

The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding the RetractoFoam device. It states that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls but does not include details of any performance studies.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).