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510(k) K083344

HELIODENT PLUS by Sirona Dental Systems GmbH — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2008
Date Received
November 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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