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510(k) K191911

3Shape Splint Design by 3Shape A/S — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2019
Date Received
July 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

Other clearances by 3Shape A/S

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  • K180941 — Ortho System (October 17, 2018)
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  • K163677 — Ortho System (April 20, 2017)
  • K161884 — Ortho System (April 19, 2017)
  • K151455 — 3Shape Abutment Designer Software (September 6, 2016)
  • K152086 — 3Shape Ortho System (April 28, 2016)

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