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510(k) Data Aggregation
K Number
K102739Device Name
HYDROCOLOR 5
Manufacturer
Date Cleared
2010-12-08
(77 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CASCADES DEVICE CONSULTING ASSOCIATES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HYDROCOLOR 5 is a conventional alginate dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
Device Description
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