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FDA · official record K093894Substantially Equivalent

ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE

United StatesEFAAnthogyr
Official record identity
FDA application number
K093894
Decision date
March 03, 2010
Published decision
Substantially Equivalent
Classification
Published parties
Applicant
Anthogyr
Additional source fields
Decision code
SESE
Published decision
Substantially Equivalent
Submission type
Special
Received date
2009-12-18
Review panel
Dental
Current product-code class (harmonized)
1
Current product-code regulation (harmonized)
872.4200
About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.