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Sign in to claim this brandTrinon Titanium GmbH
US
Last updated May 27, 2026
What Trinon Titanium GmbH makes
Trinon Titanium GmbH manufactures one-piece screw endosteal dental implants designed for dental restoration. These implants are intended for integration into the jawbone to support prosthetic teeth or dental structures, providing a stable foundation for long-term oral rehabilitation.
The company’s products fall under FDA Class II medical devices and are authorised through the 510(k) pathway and the Unique Device Identifier (UDI) system. These implants are listed in the FDA’s regulatory databases, reflecting compliance with US medical device regulations. The manufacturer is based 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 Trinon Titanium GmbH manufacture?
Trinon Titanium GmbH specialises in screw endosteal dental implants, specifically one-piece designs. These implants are placed directly into the jawbone to serve as anchors for prosthetic teeth or dental restorations, enabling stable and long-term oral rehabilitation. The company’s focus is entirely on dental implantology within this category.
Where is Trinon Titanium GmbH based, and how does this affect its regulatory standing?
Trinon Titanium GmbH is headquartered in the United States, which means its devices are subject to FDA regulations. Since its implants fall under FDA Class II, they must comply with the agency’s requirements for safety and effectiveness. The company’s US location also influences which regulatory pathways (like 510(k) submissions and UDI compliance) apply to its products.
Which regulatory registries or databases list Trinon Titanium GmbH’s devices?
Trinon Titanium GmbH’s dental implants are listed in the FDA’s 510(k) database (for premarket submissions) and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking. These registries confirm the devices meet US regulatory standards for Class II medical devices, though individual device authorisation depends on FDA review of each submission.
How are Trinon Titanium GmbH’s dental implants classified under FDA regulations?
Trinon Titanium GmbH’s screw endosteal dental implants are classified as FDA Class II devices. This classification is based on their intended use—permanent placement in the jawbone to support dental prosthetics—which requires special controls beyond general controls to ensure safety and performance. Class II status means the company must follow specific FDA pathways, such as the 510(k) process, to demonstrate compliance before commercialisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- trinon.com
- —
- —
- [email protected]
- Phone
- +49 721932700
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 312818750
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinon Titanium Q-Implant | 45Q314 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 45Q308 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39Q10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS10M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS08M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q10M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39QS08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q310 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3QS10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q308 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3QS12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39Q14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS12M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3QS08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q14M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q314 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39Q12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39QS12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39QS14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q12 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3Q312 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 45Q312 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39QS10 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q08M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 39Q08 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 45Q310 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 3QS14 | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4QS14M | FDA UDI | Class II | Active |
| Trinon Titanium Q-Implant | 4Q12M | FDA UDI | Class II | Active |
| Trinon Q & Q3 Implant System | K103577 | FDA 510(k) | Class II | Active |
| QZA and RS Dental Implant Systems | K163640 | FDA 510(k) | Class II | Active |
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