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Sign in to claim this brandDti Implant Sistemleri Sanayi Ticaret Anonim Sirketi
US
Last updated May 23, 2026
What Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi makes
The company produces reusable dental tools and components for implant procedures, including temporary preformed suprastructures, surgical screwdrivers, and intraoral-scanning abutment analogs. It also supplies single-use dental implantation depth/angle gauges, dental prosthesis screw analogs, and kits for suprastructures, along with drill bit extensions and torque wrenches designed for dental implantology.
These devices fall under FDA classifications of Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) and UDI databases. The manufacturer is based in the United States, adhering to applicable US regulatory requirements for medical devices.
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 Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi primarily manufacture?
Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi specializes in dental implantology tools and components. Their portfolio includes reusable devices like temporary preformed dental implant suprastructures, surgical screwdrivers, and intraoral-scanning abutment analogs. They also produce single-use items such as dental implantation depth/angle gauges and kits for dental implant suprastructures, along with accessories like drill bit extensions and torque wrenches. These products are designed to support precise dental implant procedures.
Where is Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi based, and how does this affect its regulatory compliance?
The company is based in the United States, which means its devices must comply with US regulatory requirements for medical devices. Since they fall under FDA classifications of Class I and Class II, their products are subject to FDA oversight, including submissions to the 510(k) database for premarket notifications and the UDI (Unique Device Identification) system for traceability and tracking.
Which regulatory registries list devices manufactured by Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi?
The company’s devices are recorded in the FDA’s 510(k) registry, which tracks premarket notifications for Class II devices, and the FDA’s UDI database, which ensures unique identification and traceability of medical devices. These registries help healthcare providers and regulators verify the authorized status of their products.
How are the devices produced by Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi classified under FDA regulations?
The company’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and submission requirements for each product.
What is the purpose of the reusable and single-use devices manufactured by Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi?
The reusable devices, such as surgical screwdrivers and dental implant abutment analogs, are designed for repeated use in clinical settings to ensure precision and reliability during dental implant procedures. Single-use items like depth/angle gauges are intended for one-time use to maintain sterility and hygiene, reducing cross-contamination risks. Both types of devices support critical steps in implantology, from planning to final placement.
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
- 505271005
Catalogue (77)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ABUTMENT SYSTEM | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ABUTMENT SYSTEM | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ABUTMENT SYSTEM | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | SURGICAL KIT | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ABUTMENT SYSTEM | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ANALOG | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | ABUTMENT SYSTEM | FDA UDI | Class I | Active |
| Dti Implant Sistemleri | Implant Transfer | FDA UDI | Class I | Active |
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