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510(k) K191911

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

K191911 is an FDA 510(k) premarket notification submitted by 3Shape A/S for the device "3Shape Splint Design". The FDA issued a decision of Substantially Equivalent on November 27, 2019. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. 3Shape A/S has at least 7 other 510(k) clearances on record.

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

  • K200100 — Abutment Design (October 7, 2020)
  • K180941 — Ortho System (October 17, 2018)
  • K171634 — Ortho System (January 17, 2018)
  • 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)

Other clearances for product code PNN

  • K260419 — LingOral Dental Design System (May 8, 2026)
  • K253565 — SureSmile Software (March 4, 2026)
  • K252507 — SmileInspector (January 7, 2026)
  • K253343 — Celebrace Software (December 29, 2025)
  • K250198 — Laon Ortho (April 23, 2025)
  • K241153 — Progressive Orthodontics App (October 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232564 — Align Studio (March 12, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
  • K232549 — NemoCast (November 21, 2023)

FDA data resources