510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191911Substantially Equivalent

3Shape Splint Design

3Shape A/S, Copenhagen, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191911 is the FDA 510(k) clearance record for 3Shape Splint Design, a class II device, cleared for 3Shape A/S on under FDA product code PNN (Orthodontic Software). FDA's definition for product code PNN reads: "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...". FDA records list 8 510(k) clearances for 3Shape A/S, from to . As of , FDA records show no recalls naming K191911.

Clearance record

Decision date
Received
(133 days to decision)
Product code
PNN Orthodontic Software
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
3Shape A/S
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNN

Trailing 12 months
5 clearances under product code PNN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260