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510(k) Data Aggregation
K Number
K080146Device Name
ZIRKONDENT
Manufacturer
Date Cleared
2008-06-06
(136 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ERGOMETA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Zirkondent is indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses.
Device Description
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