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510(k) K133178

LUXATOR LX HANDPIECE by Directa AB — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2015
Date Received
October 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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