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FDA 510(k) Application Details - K161488
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K161488
Device Name
Unit, Operative Dental
Applicant
KALTENBACH & VOIGT GMBH
BISMARCKRING 39
BIBERACH 88400 DE
Other 510(k) Applications for this Company
Contact
STEFAN TRAMPLER
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2016
Decision Date
12/08/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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