LogoFDA 510(k) Search
K Number
K081017
Device Name
TEMPLATE AND COUNTER-FIT
Manufacturer
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Date Cleared
2008-08-04

(117 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

Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter acknowledges that the device (Template and CounterFit) is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. However, it does not detail any performance studies, test results, ground truth establishment, or sample sizes related to the device's technical specifications.

Therefore, I cannot provide the requested information based on the provided text.

§ 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).