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Sign in to claim this brand3shape A/S
US
Last updated May 24, 2026
What 3shape A/S makes
3shape A/S develops dental milling systems and CAD/CAM software tailored for laboratory use, including devices for scanning dental models and designing restorations such as abutments and splints. Their portfolio also includes specialized software applications for dental treatment planning, including orthodontic workflows and implant design tools.
The company’s devices are classified under Class II and Class U, with regulatory authorisation through FDA 510(k) clearances and FDA UDI listings. These products are intended for use in the United States, where the manufacturer is based.
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 A/S manufacture?
3shape A/S specializes in dental devices primarily used in laboratory settings. Their portfolio includes CAD/CAM milling systems for creating dental restorations, as well as software applications for designing dental treatments. Examples include devices for scanning dental models (Lab Scanner), designing abutments and splints (Abutment Design, Splint Design), and specialized software for orthodontic workflows (Ortho System) and implant planning (Implant Studio). These tools are designed to streamline workflows for dental laboratories and clinicians.
Where is 3shape A/S based, and what is its primary market?
3shape A/S is based in the United States. While the company develops its devices globally, its primary market focus is the U.S., where its products are intended for use. The devices are tailored to meet regulatory requirements and workflows specific to this market.
How are 3shape A/S’s devices classified under U.S. regulations?
3shape A/S’s devices fall under two primary regulatory classifications in the U.S.: Class II and Class U. Class II devices generally require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a predicate device, while Class U devices are exempt from certain regulatory requirements but still must comply with UDI (Unique Device Identification) rules. The company’s portfolio includes both types, depending on the specific function and risk level of the device.
Which regulatory registries or databases list 3shape A/S’s devices?
3shape A/S’s devices are listed in the FDA’s 510(k) database for Class II devices, which requires premarket notification clearance. Additionally, their devices appear in the FDA’s UDI (Unique Device Identification) system, ensuring traceability and compliance with identification requirements. These listings help ensure transparency and accessibility for regulatory oversight and market surveillance.
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
- 306826012
Catalogue (175)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3Shape Scan Bodies | SBsys | FDA UDI | Class II | Unknown |
| 3Shape scan bodies | NGY | FDA UDI | Class II | Unknown |
| Automate | R2b | FDA UDI | Class II | Active |
| Lab Scanner | D700 | FDA UDI | Class II | Unknown |
| Lab Scanner | A21 | FDA UDI | Class II | Unknown |
| Lab Scanner | A36.I | FDA UDI | Class II | Unknown |
| 3Shape Scan Posts | PL1.6 | FDA UDI | Class II | Unknown |
| Lab Scanner | D1000 | FDA UDI | Class II | Unknown |
| Lab Scanner | A63.I | FDA UDI | Class II | Unknown |
| Lab Scanner | A64 | FDA UDI | Class II | Unknown |
| 3Shape scan bodies | NCG | FDA UDI | Class II | Unknown |
| Lab Scanner | R1000 | FDA UDI | Class II | Unknown |
| 3Shape scan bodies | NCP | FDA UDI | Class II | Unknown |
| 3Shape Scan Posts | AL1.6 | FDA UDI | Class II | Unknown |
| Lab Scanner | A46.E | FDA UDI | Class II | Unknown |
| 3Shape Scan Bodies | BCsys | FDA UDI | Class II | Unknown |
| 3Shape scan bodies | NGP | FDA UDI | Class II | Unknown |
| Abutment Design | K200100 | FDA 510(k) | Class II | Active |
| 3Shape Ortho System | K152086 | FDA 510(k) | Class II | Active |
| Ortho System | K163677 | FDA 510(k) | Class II | Active |
| 3Shape Splint Design | K191911 | FDA 510(k) | Class II | Active |
| 3Shape Abutment Designer Software | K151455 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Ortho System | K171634 | FDA 510(k) | Class II | Active |
| Ortho System | K161884 | FDA 510(k) | U | Active |
| Ortho System | K180941 | FDA 510(k) | Class II | Active |
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