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510(k) Data Aggregation
K Number
K152349Device Name
Star+ VPS Scannable Impression Material
Manufacturer
DANVILLE MATERIALS LLC
Date Cleared
2015-11-23
(95 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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K Number
K151514Device Name
Prestige
Manufacturer
DANVILLE MATERIALS LLC
Date Cleared
2015-09-21
(108 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prestige is a dental composite restorative material designed to be used in all classes of cavities
Device Description
Prestige™ is a light-cured, Nanohybrid dental restorative material intended for use for the restoration in all classes of cavities
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