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510(k) K101612

ZEN CORDLESS PROPHY SYSTEM by Discus Dental, LLC — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2010
Date Received
June 9, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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