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510(k) K021378

PORTABLE HDX INTRAORAL X-RAY by Dentalez Group — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2002
Date Received
May 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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