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K Number
K152349
Device Name
Star+ VPS Scannable Impression Material
Manufacturer
DANVILLE MATERIALS LLC
Date Cleared
2015-11-23

(95 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

Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, and implant techniques. The impression material can also be scanned by dental impression scanners

Device Description

Star+ VPS Scannable Impression Material is an addition-cured vinyl polysiloxane dental impression material.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for a dental impression material, and it primarily focuses on the regulatory approval process and indications for use, rather than detailed performance study results.

§ 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).