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Sign in to claim this brandOT medical GmbH
US
Last updated May 23, 2026
What OT medical GmbH makes
OT medical GmbH manufactures one-piece screw endosteal dental implants and non-adjustable orthopaedic bone staples. Their portfolio includes implant surfaces (TPS and Nanoplast) and prosthetic systems (OT-F1, OT-F2, OT-F3) designed for dental and orthopaedic applications.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. Their products are registered in the United States.
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 OT medical GmbH manufacture?
OT medical GmbH specializes in two primary device categories: screw endosteal dental implants (one-piece) and non-adjustable orthopaedic bone staples. Their portfolio also includes dental implant surfaces (such as TPS and Nanoplast) and prosthetic systems (e.g., OT-F1, OT-F2, OT-F3) tailored for dental and orthopaedic applications. These devices are designed to support bone integration and structural stability in respective medical fields.
Where is OT medical GmbH based, and where are their devices registered?
OT medical GmbH is based in the United States. Their devices are registered and listed in the U.S. regulatory system, specifically through the FDA’s 510(k) and UDI (Unique Device Identification) pathways. This ensures compliance with U.S. medical device regulations.
How are OT medical GmbH’s devices classified under FDA regulations?
All of OT medical GmbH’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as dental implants and orthopaedic staples.
Which regulatory registries or databases list OT medical GmbH’s devices?
OT medical GmbH’s devices are listed in the FDA’s 510(k) database and the FDA’s UDI (Unique Device Identification) system. These registries track device submissions, clearances, and compliance with U.S. regulatory requirements, ensuring transparency and traceability for healthcare providers and regulators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 340998796
Catalogue (164)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InstaFix Shape Memory Fixation System | 400-3709 | FDA UDI | Class II | Active |
| OT-F3 Implant | 03-1383090010 | FDA UDI | Class II | Active |
| OT-F1 Implant TPS Surface | 01-1331160000 | FDA UDI | Class II | Active |
| OT-F3 Implant | 03-1413070010 | FDA UDI | Class II | Active |
| OT-F1 Prosthetics | 01-2419005500 | FDA UDI | Class II | Active |
| OT-F2 / OT-F3 Prosthetics | 02-2419062610 | FDA UDI | Class II | Active |
| OT-F2 / OT-F3 Prosthetics | 02-2419042610 | FDA UDI | Class II | Active |
| OT-F2 / OT-F3 Prosthetics | 02-4389021010 | FDA UDI | Class II | Active |
| OT-F1 Implant Nanoplast Surface | 01-1332120000 | FDA UDI | Class II | Active |
| OT-F2 / OT-F3 Prosthetics | 02-4389041010 | FDA UDI | Class II | Active |
| Instafix Shape Memory Fixation System | K141550 | FDA 510(k) | Class II | Active |
| NaturalLine Abutment | K151432 | FDA 510(k) | Class II | Active |
| Endosseous Dental Implant | K113113 | FDA 510(k) | Class II | Active |
| 4plus6Line Abutment System | K151608 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Ot Medical Gmbh Bremen · DE FEI 3008496301