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FDA 510(k) Application Details - K070246
Device Classification Name
Gutta-Percha
More FDA Info for this Device
510(K) Number
K070246
Device Name
Gutta-Percha
Applicant
ENDO TWINN B.V.
DANZIGERKADE 17
AMSTERDAM 1013 AP NL
Other 510(k) Applications for this Company
Contact
F.M. VERHOEVEN
Other 510(k) Applications for this Contact
Regulation Number
872.3850
More FDA Info for this Regulation Number
Classification Product Code
EKM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2007
Decision Date
02/16/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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