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Sign in to claim this brand3shape Trios A/S
US
Last updated May 24, 2026
What 3shape Trios A/S makes
3shape Trios A/S manufactures intraoral optical scanning systems for capturing digital impressions of dental structures, as well as CAD/CAM dental milling systems designed for both laboratory and chairside use. Their portfolio includes devices for intraoral scanning and scan bodies used in restorative dentistry workflows, enabling precise digital records for crowns, bridges, and other dental prosthetics.
The company’s devices are regulated under FDA classifications, including Class I and Class II, and are listed under the 510(k) and UDI programs. Their products are based in the United States and comply with applicable regulatory requirements for dental imaging and milling systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does 3shape Trios A/S manufacture?
3shape Trios A/S specializes in dental devices, including intraoral optical scanning systems for capturing digital impressions of teeth and gums, as well as CAD/CAM dental milling systems. These systems are used in both laboratory and chairside settings to create precise digital records for dental restorations like crowns, bridges, and other prosthetics. Their portfolio also includes scan bodies, which are used in conjunction with intraoral scanners to aid in the fabrication of dental restorations.
Where is 3shape Trios A/S based, and how does this affect its regulatory oversight?
3shape Trios A/S is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The company’s products are classified under FDA categories, including Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). This classification determines the regulatory pathway, such as the 510(k) premarket notification process or UDI (Unique Device Identification) requirements, ensuring compliance with U.S. medical device regulations.
Which regulatory registries or databases list 3shape Trios A/S devices?
3shape Trios A/S devices are listed in the FDA’s 510(k) database, which tracks premarket submissions for Class II devices requiring special controls, and the FDA’s UDI (Unique Device Identification) system. These registries help ensure transparency and traceability of the company’s products under U.S. medical device regulations. Listing in these databases confirms compliance with FDA requirements for device identification and classification.
How are 3shape Trios A/S devices classified under FDA regulations?
3shape Trios A/S devices are classified under FDA’s risk-based system as either Class I or Class II. Class I devices, such as some intraoral scanners, are typically low-risk and may only require general controls like good manufacturing practices. Class II devices, including certain CAD/CAM milling systems, require additional regulatory oversight, such as the 510(k) process, to ensure their safety and performance meet FDA standards. Classification depends on factors like intended use, risk level, and technological complexity.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- 3shape.com
- —
- —
- [email protected]
- Phone
- +4570272620
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 305225025
Catalogue (256)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3Shape Scan Bodies | OTsys | FDA UDI | Class I | Active |
| 3Shape | A47.SB | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | BEbox | FDA UDI | Class I | Unknown |
| 3Shape Scan Bodies | NGY | FDA UDI | Class I | Active |
| Trios® 4 | S3A-22 | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | ZTP | FDA UDI | Class I | Active |
| Trios | TRIOS Protection Tip | FDA UDI | Class II | Unknown |
| Trios® | P13-tip | FDA UDI | Class II | Active |
| Trios® | TB-031-W | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | SBR | FDA UDI | Class I | Active |
| Trios® 4 | S3A-14 | FDA UDI | Class II | Unknown |
| PrograScan One+ | TSC-01 | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | NRR | FDA UDI | Class I | Active |
| Trios 3 | TRIOS 3 cart | FDA UDI | Class II | Unknown |
| Trios® | TB-03 | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | BCsys | FDA UDI | Class I | Active |
| Trios 6 | L1P-2 | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | BIsys | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | BCP | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | NGB | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | DE | FDA UDI | Class I | Active |
| Trios® 3 | S1P-4 | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | BCbox | FDA UDI | Class I | Unknown |
| 3Shape Scan Bodies | NRsys | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | NGG | FDA UDI | Class I | Active |
| Trios® 3 | S1-2 | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | SBN | FDA UDI | Class I | Active |
| Trios® 3 | S1A-1 | FDA UDI | Class II | Unknown |
| Trios | TST-11 | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | BCY | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | NR6 | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | SSN | FDA UDI | Class I | Active |
| Trios | TSL-01 | FDA UDI | Class II | Active |
| TRIOS Core | S1P-4 | FDA UDI | Class II | Active |
| 3Shape Scan Bodies | NBW | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | NGsys | FDA UDI | Class I | Active |
| Trios® | TB-02 | FDA UDI | Class II | Unknown |
| Trios® 3 | S1-ACC-2 | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | DYsys | FDA UDI | Class I | Active |
| Trios® 3 | S2A-1 | FDA UDI | Class II | Unknown |
| Trios | TRIOS Standard- Scanner Tip | FDA UDI | Class II | Unknown |
| Trios® 3 | S2P-2 | FDA UDI | Class II | Active |
| Trios 3 | TRIOS 3 battery cart | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | NAbox | FDA UDI | Class I | Unknown |
| 3Shape Scan Bodies | DXG | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | NBN | FDA UDI | Class I | Active |
| 3Shape Scan Bodies | OTR | FDA UDI | Class I | Active |
| Trios® 3 | S2-3 | FDA UDI | Class II | Unknown |
| Trios® 3 | PS1-1 | FDA UDI | Class II | Active |
| Trios® 4 | S3P-2 | FDA UDI | Class II | Active |
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