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510(k) K160506

Planmeca ProMax 3D Max, Planmeca Maximity by Planmeca Oy — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
February 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other clearances by Planmeca Oy

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  • K200572 — Planmeca Romexis (December 2, 2020)
  • K181576 — Planmeca Viso (September 13, 2018)
  • K171385 — Planmeca Romexis (November 14, 2017)
  • 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)
  • K060328 — PLANMECA PROMAX 3D (March 15, 2006)

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