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510(k) K112665

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE by J. Morita USA, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
September 13, 2011
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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