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K Number
K973694
Device Name
PROVIL NOVO
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
1997-11-24

(59 days)

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

Provil novo is a silicone based, addition curing impression material used for all inlay, crown and bridge, edentulous a partial impressions.

Device Description

Provil novo is a silicone based, addition curing impression material.

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA related to a 510(k) premarket notification for a dental impression material named "Provil novo". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

§ 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).