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510(k) K090931

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR by W&H Dentalwerk Buermoos GmbH — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2009
Date Received
April 2, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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