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510(k) K960028

ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM by Dentsply Intl. — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1996
Date Received
January 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

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