510(k) K092446

INTRA LUX HEAD 3 LDSY by Kaltenbach & Voigt GmbH & Co. — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2009
Date Received
August 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type