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510(k) K161884

Ortho System by 3Shape A/S — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2017
Date Received
July 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by 3Shape A/S

  • K200100 — Abutment Design (October 7, 2020)
  • K191911 — 3Shape Splint Design (November 27, 2019)
  • K180941 — Ortho System (October 17, 2018)
  • K171634 — Ortho System (January 17, 2018)
  • K163677 — Ortho System (April 20, 2017)
  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)
  • K152086 — 3Shape Ortho System (April 28, 2016)

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