3shape.comTRIOS Ready Tip
3Shape TRIOS A/S
3SHAPE TRIOS A/S
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009560013 | 3009560013 | 3SHAPE TRIOS A/S | 1 | N | 2026-01-01 | Holmens Kanal 7 copenhagen Hovedstaden DK 1060 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05902729753852 | TRIOS 3 - Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner | +4570272620 | support@3shape.com |
| 05902729753869 | TRIOS 3 - Color pen-grip intraoral scanner w. protection tip | +4570272620 | support@3shape.com |
| 05902729753876 | TRIOS Core - Color pen-grip intraoral scanner w. protection tip | +4570272620 | support@3shape.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 139783 | 1185670927 | K260082 | TRIOS Dx (R1) | SHQ | 2026-04-10 |
| 139783 | 1669311480 | K242103 | TRIOS Ready Tip | NBL | 2025-04-04 |
| 139783 | 1567106466 | K221249 | L1P-1F (TRIOS 5) | NBL | 2022-09-16 |
| 139783 | 1278257567 | ||||
| 139783 | 1809842843 | ||||
| 139783 | 1281181960 |
Product Codes Associated With Registrations
PMN
L1P-1F (TRIOS 5)
3Shape TRIOS A/S
GUDID
TRIOS 5 - The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
2025-06-16
TRIOS Ready Tip - TST-15
2025-05-06
TRIOS 6 - L1P-2
2025-04-24
TRIOS® 3 - Scanner tip w. mirror (autoclavable)
2025-04-01
TRIOS Patient Monitoring - The TRIOS Patient Monitoring software can be used for the visualization and comparison of 3D scans of the dentition.
2024-10-30
TRIOS 3 - Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
2024-05-17
TRIOS 3 - Color pen-grip intraoral scanner w. protection tip
2024-05-17
TRIOS Core - Color pen-grip intraoral scanner w. protection tip
2024-05-17
TRIOS Core - Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
2024-05-17
TRIOS 3 - Pod for Pen-grip configuration
2024-05-17
Trios Move+ - C4.1
2023-09-06
3Shape F8 - The 3Shape F8 is used to record the topographical characteristics of the dentition by scanning objects, for example teeth, dental gypsum or impression models that can include scan bodies. A 3D model is created, which can further be annotated and corrected for scan artifacts.
2023-01-18
TRIOS Patient Monitoring - Monitoring of changes in the dentition over time by comparison of TRIOS 3D images
2021-05-28
TRIOS - TB-04
2022-09-26
TRIOS - C2BP
2022-09-26
TRIOS - LP1-2
2022-09-26
TRIOS 5 - L1P-1F
2022-09-26
TRIOS 5 - L1-2
2022-09-26
TRIOS - TST-11
2022-09-26
TRIOS - TSL-01
2022-09-26
TRIOS - TST-13
2022-09-26
3Shape Scan Bodies - Neodent Cone Morse Screwdriver
2019-12-20
3Shape Scan Bodies - Complete kit
2019-12-20
3Shape Scan Bodies - Neodent Grand Morse Screwdriver
2019-12-20
3Shape Scan Bodies - Complete kit
2019-12-20
TRIOS® - Color calibaration kit
2019-05-14
Automate - DentalSystem-backed web service for automatic designs of crowns.
2021-05-31
3Shape Scan Bodies - Nobel Active - Narrow platform - Connection: 3,0
2021-05-25
3Shape Scan Bodies - Nobel Active - Narrow platform - Connection: 3,5
2021-05-25
3Shape Scan Bodies - Bonelevel - Narrow platform - Connection: NC (Ø3,0)
2021-05-24
3Shape Scan Bodies - TSV - Wide platform - Connection: 5,7
2021-05-24
3Shape Scan Bodies - TSV - Regular platform - Connection: 4,5
2021-05-24
3Shape Scan Bodies - TSV - Regular platform - Connection: 3,5
2021-05-24
3Shape Scan Bodies - TSV - Screwdriver
2021-05-24
3Shape Scan Bodies - Synocta - Wide platform - Connection: WN (Ø6,5)
2021-05-24
3Shape Scan Bodies - Synocta - Regular platform - Connection: RN (Ø4,8)
2021-05-24
3Shape Scan Bodies - Synocta - Narrow platform - Connection: NN (NNC) (Ø3,5)
2021-05-24
3Shape Scan Bodies - Synocta - Screwdriver
2021-05-24
3Shape Scan Bodies - Bonelevel - Regular platform - Connection: RC (Ø3,75)
2021-05-24
3Shape Scan Bodies - Bonelevel - Screwdriver
2021-05-24