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510(k) K072244

PLANMECA PROONE by Planmeca Oy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2007
Date Received
August 13, 2007
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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  • K140713 — PLANMECA ROMEXIS (June 16, 2014)
  • K103689 — PLANMECA PROMAX 3D MID (March 17, 2011)
  • K093590 — PLANMECA PROMAX 3D MAX (May 12, 2010)
  • K091197 — PLANMECA PROSENSOR (July 29, 2009)
  • K060328 — PLANMECA PROMAX 3D (March 15, 2006)

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