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K Number
K983106
Device Name
1ST IMPRESSION
Manufacturer
DEN-MAT CORP.
Date Cleared
1999-02-09

(158 days)

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

Utilized by a dental Heath-care profession.) for making high-definition dental impressions. as port of dental prosthesis procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a 510(k) premarket notification letter from the FDA, discussing the substantial equivalence of a dental impression device, but it lacks the specific technical details you're looking for.

§ 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).