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510(k) K091197

PLANMECA PROSENSOR by Planmeca Oy — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2009
Date Received
April 23, 2009
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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  • 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)
  • K072244 — PLANMECA PROONE (September 21, 2007)
  • K060328 — PLANMECA PROMAX 3D (March 15, 2006)

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