Manufacturer registered with FDA
3Shape Trios
copenhagen, Denmark. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 15
- 510(k) clearances
- 32022–2026
- Markets registered in
- 15157 registrations outside the US
- Establishments
- 1Denmark
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name 3Shape Trios 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 Trios | 3 clearances | 2022–2026 | Below |
| Canada | Health Canada | Registration holder | 3SHAPE TRIOS A/S | 65 | 2016–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | 3SHAPE TRIOS A/S3Shape TRIOS A/S · 3 SHAPE TRIOS A/S | 16 | 2012–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | 3shape TRIOS A/S | 13 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | 3SHAPE TRIOS A/S3Shape TRIOS A/S · 3 SHAPE TRIOS A/S | 12 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | 3Shape TRIOS A/S | 12 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | 3Shape TRIOS A/S | 11 | — | Pure Global AI |
| Australia | TGA | Manufacturer | 3Shape Trios AS | 7 | 2019–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | 3Shape TRIOS A/S | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | 3Shape TRIOS A/S | 5 | 2023–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3SHAPE TRIOS A/S | 4 | 2023–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | 3SHAPE TRIOS A/S3 SHAPE TRIOS A/S | 3 | 2021–2025 | Pure Global AI |
| China | NMPA | Registration holder | 泰夫恩口内扫描设备有限公司3Shape TRIOS A/S | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | 3SHAPE TRIOS A/S | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | 3Shape TRIOS 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 Trios currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | L1P-1FTrios 5 (L1P-1F)Trios Ready Tip | 2022 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | S1P-2 scanning tipTrios 3TRIOS 3 WirelessTRIOS 4Trios 6Trios CoreTrios Interoral Dental SystemTrios Move ProTrios Move+TRIOS Patient Monitoring 1 more3Shape F8 | 2012 |
| 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 Trios as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Apr 2026 | K260082 | TRIOS Dx (R1) | SHQ In-Office Dental Image Analyzer |
| 4 Apr 2025 | K242103 | TRIOS Ready Tip | NBL Light-Induced Fluorescence Caries Detector |
| 16 Sep 2022 | K221249 | L1P-1F (TRIOS 5) | NBL Light-Induced Fluorescence Caries Detector |
Some of these clearances are listed with FDA today by another company: 3Shape A/S (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3SHAPE TRIOS A/SFDA reg. 3009560013 | copenhagen Hovedstaden, Denmark | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040244). 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.