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K Number
K972871
Device Name
GENESIS
Manufacturer
PACIFIC RIM DENTAL, INC.
Date Cleared
1997-10-02

(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

For use by a dental professional in obtaining a reproduction of teeth and investing tissues, as needed.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA document does not contain information on the acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications. The document is an FDA 510(k) clearance letter for a dental device called "Genesis Alginato," indicating its substantial equivalence to a legally marketed predicate device for obtaining reproductions of teeth and investing tissues. It outlines regulatory requirements and allows the manufacturer to market the device, but it does not include the technical performance evaluation data you are requesting.

§ 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).