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3Shape Splint Design

by 3Shape A/S

510(k) K191911

3Shape Splint Design is a medical device (FDA Class II; FDA product code PNN, Orthodontic Software) made by 3Shape A/S, cleared under FDA 510(k) K191911 on 27 Nov 2019, active as of 23 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191911 Date27 Nov 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PNN
Device class
Class II
Regulation
21 CFR Part 872.5470
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K191911

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191911
UDI-DISize and differences
Splint Design 1.1.x
3Shape A/S
1.1.x05902729752954 —No longer on the market
Splint Design R1.0
3Shape A/S
R1.005902729753555 —On the market

Similar devices

Other devices filed under FDA product code PNN (Orthodontic Software).

Other devices from 3Shape A/S

See all devices from 3Shape A/S →