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510(k) K000454

DIMEX 2 by Planmeca Oy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2000
Date Received
February 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K091197 — PLANMECA PROSENSOR (July 29, 2009)
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