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510(k) K051464

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) by Planmeca Oy — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2005
Date Received
June 3, 2005
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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  • K093590 — PLANMECA PROMAX 3D MAX (May 12, 2010)
  • K091197 — PLANMECA PROSENSOR (July 29, 2009)
  • K072244 — PLANMECA PROONE (September 21, 2007)

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