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510(k) Data Aggregation
K Number
K983876Device Name
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
Manufacturer
MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND
Date Cleared
1998-12-16
(44 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.
Device Description
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