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510(k) K100600

PROSTHODONTIC SCREWDRIVER , MODEL IA-400 by W&H Dentalwerk Buermoos GmbH — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
March 3, 2010
Clearance Type
Traditional
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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