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K Number
K970129
Device Name
TULIP
Manufacturer
RICHARD TING
Date Cleared
1997-08-18

(215 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

THE DENTAL ALGINATE IMPRESSION MATERIAL IS JSED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DEVIURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES.

Device Description

DENTAL ALGINATE IMPRESSION MATERIAL

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental alginate impression material from 1997. It describes the regulatory approval of the device but does not contain any information about acceptance criteria, study data, performance metrics, or details of a study used to prove the device meets acceptance criteria.

Therefore, I cannot extract the requested information.

§ 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).