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510(k) Data Aggregation
K Number
K970594Device Name
KALGINATE IMPRESSION MATERIAL
Manufacturer
Date Cleared
1997-03-31
(41 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
TELEDYNE WATER PIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient's teeth and oral tissues.
Device Description
Kalginate ® is a powdered material, that is mixed with water and placed in the patients oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patients teeth and oral tissues.
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