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K Number
K012767
Device Name
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
Manufacturer
S & C POLYMER GMBH
Date Cleared
2001-11-01

(76 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

S & C Hydro Vinyl Polysiloxane Impression Material is intended to be placed into a syringe for delivery around a tooth or on a preformed impression tray for placement in the mouth, and used to reproduce the structure of a patient's teeth and gums.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a dental impression material, outlining the regulatory approval process and general compliance requirements. It does not include specific performance studies or data.

§ 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).