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510(k) K060328

PLANMECA PROMAX 3D by Planmeca Oy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2006
Date Received
February 9, 2006
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

Other clearances by Planmeca Oy

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  • K171385 — Planmeca Romexis (November 14, 2017)
  • K160506 — Planmeca ProMax 3D Max, Planmeca Maximity (May 20, 2016)
  • 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)
  • K072244 — PLANMECA PROONE (September 21, 2007)

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