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FDA 510(k) Application Details - K030146
Device Classification Name
Laser, Dental, Soft Tissue
More FDA Info for this Device
510(K) Number
K030146
Device Name
Laser, Dental, Soft Tissue
Applicant
KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH, IL 60047 US
Other 510(k) Applications for this Company
Contact
J0HN R FRANZ
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NVK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/15/2003
Decision Date
08/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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