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510(k) Data Aggregation
K Number
K053018Device Name
POLY SILOXANE IMPRESSION MATERIAL
Manufacturer
MILLENNIUM DENTAL INTERNATIONAL, INC.
Date Cleared
2005-11-08
(13 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM DENTAL INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Device Description
Multiple (POLY SILOXANE IMPRESSION MATERIAL)
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