Manufacturer registered with FDA
3Shape A/S
Copenhagen K, Denmark. Lists 5 dental device types with FDA across 4 registered establishments, and holds 7 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 53
- 510(k) clearances
- 72016–2020
- Markets registered in
- 15293 registrations outside the US
- Establishments
- 4Denmark, Poland, United States
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name 3Shape A/S as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | 3Shape A/S | 7 clearances | 2016–2020 | Below |
| South Korea | MFDS | Manufacturer | 3Shape Poland Sp. z o.o.3Shape Poland Sp.z.o.o. · 3Shape Poland Sp. z.o.o. · +2 | 173 | 2012–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | 3SHAPE A/S3Shape Poland Sp. zo.o. · 3SHAPE POLAND SP. Z O.O. · +2 | 31 | 2012–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | 3SHAPE S.A.S3SHAPE A/S | 29 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | 3SHAPE A/S3Shape A/S · 3SHAPE POLAND SP. Z. O. O. · +1 | 14 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | 3SHAPE A/S | 11 | 2014–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | 3Shape A/S3Shape Poland Sp. Z.O.O. | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | 3Shape A/S | 6 | 2016–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | 3Shape A/S | 6 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | 3Shape A/S | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | 3Shape A/S | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | 3Shape A/S | 2 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3SHAPE A/S | 1 | 2023–2023 | Pure Global AI |
| China | NMPA | Registration holder | 三炫谱有限公司3Shape A/S | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | 3Shape A/S | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What 3Shape A/S currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Ortho System3Shape Ortho System3Shape Splint Design | 2016 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | L1P-1FTrios 5 (L1P-1F) | 2022 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | AutomateE1 scannerE2 ScannerE3 ScannerE4 ScannerNovux D2000Novux D750Novux D850Novux E1 ScannerNovux E2 Scanner 35 moreNovux E3 ScannerNovux E4 ScannerPuffinS1P-2 scanning tipTrios 3TRIOS 3 WirelesTRIOS 4Trios 6Trios Interoral Dental SystemTrios Move ProTrios Move+TRIOS Patient MonitoringTRIOS Scanner3D Scanner D10003D Scanner D20003D scanner D5003D Scanner D7003D scanner D7103D Scanner D7503D Scanner D8003D Scanner D8103D Scanner D8503D scanner D9003D scanner D900L3D Scanner R10003D Scanner R20003D scanner R5003D Scanner R7003D scanner R7103D Scanner R7503D Scanner R8503D scanner R9003Shape Anatomy Design3Shape Dental System3Shape F8 | 2007 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Abutment DesignAbutment designer | 2017 |
| In-Office Dental Image AnalyzerSHQ · Class 2 | — | Maker | Trios Dx | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names 3Shape A/S as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Oct 2020 | K200100 | Abutment Design | PNP Dental Abutment Design Software for Dental Laboratory |
| 27 Nov 2019 | K191911 | 3Shape Splint Design | PNN Orthodontic Software |
| 17 Oct 2018 | K180941 | Ortho System | PNN Orthodontic Software |
| 17 Jan 2018 | K171634 | Ortho System | PNN Orthodontic Software |
| 20 Apr 2017 | K163677 | Ortho System | PNN Orthodontic Software |
| 6 Sep 2016 | K151455 | 3Shape Abutment Designer Software | PNP Dental Abutment Design Software for Dental Laboratory |
| 28 Apr 2016 | K152086 | 3Shape Ortho System | PNN Orthodontic Software |
Also lists devices cleared under other names
3Shape A/S lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: 3Shape Trios (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Apr 2025 | K242103 | TRIOS Ready Tip | 3Shape Trios | NBL Light-Induced Fluorescence Caries Detector |
| 16 Sep 2022 | K221249 | L1P-1F (TRIOS 5) | 3Shape Trios | NBL Light-Induced Fluorescence Caries Detector |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3Shape A/SFDA reg. 3005940400 | Copenhagen Hovedstaden, Denmark | Manufacturer, Specification developer |
| 3shape incFDA reg. 3010728558 | New Providence, NJ, United States | Complaint file establishment |
| 3Shape Inc.FDA reg. 3015193486 | Morrisville, NC, United States | Contract manufacturer |
| 3Shape Poland Sp. zo.oFDA reg. 3015172511 | Szczecin Zachodniopomorskie, Poland | Contract manufacturer |
Other names on FDA records
3Shape Poland Sp. zo.o.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023901). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.