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Sign in to claim this brandNTI - Kahla GmbH Rotary Dental Instruments
Germany·DE-MF-000009451
Last updated May 26, 2026
What NTI - Kahla GmbH Rotary Dental Instruments makes
NTI - Kahla GmbH produces reusable dental burs, including diamond and carbide types for clinical use, as well as laboratory burs for dental prosthetics. Their portfolio also includes pin/post drill bits, laboratory mandrels, and endodontic enlargers, alongside reusable abrasive points for dental procedures.
These devices are classified as Class I under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in Germany.
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 NTI - Kahla GmbH primarily manufacture?
NTI - Kahla GmbH specializes in reusable dental instruments, including diamond and carbide dental burs for clinical procedures, as well as dental laboratory burs for creating prosthetics. Their portfolio also covers pin/post drill bits, laboratory mandrels, endodontic enlargers, and reusable abrasive points. These tools are designed for precision tasks in both patient care and dental lab environments.
Where is NTI - Kahla GmbH based, and how does this affect its devices?
NTI - Kahla GmbH is based in Germany, which means its devices comply with European Union regulations and may also follow global standards like those of the FDA. The company’s location ensures adherence to stringent manufacturing and quality control practices, particularly relevant for reusable medical instruments where sterility and durability are critical.
Which regulatory registries list NTI - Kahla GmbH’s devices, and why?
NTI - Kahla GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion is because the FDA requires Class I devices—like those produced by the company—to carry a UDI for traceability and regulatory tracking. Listing in the UDI database helps ensure transparency and compliance with U.S. medical device regulations.
How are NTI - Kahla GmbH’s dental instruments classified under regulatory frameworks?
NTI - Kahla GmbH’s dental instruments are classified as Class I devices. This classification applies to low-risk medical tools like reusable burs and drill bits, where the risk of harm to patients is minimal. Class I devices typically undergo less stringent premarket review but still require compliance with good manufacturing practices to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 3, Im Camisch, Kahla, Germany
- Website
- www.nti.de
- —
- —
- [email protected]
- Phone
- +49364245730
- PRRC Contact
- Jana Brief
- EUDAMED SRN
- DE-MF-000009451
- FDA FEI Number
- —
- DUNS Number
- 314810326
Catalogue (1413)
Page 11 of 29| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nti | 909-037M-FGK | FDA UDI | Class I | Active |
| Nti | W6196.204.090 | FDA UDI | Class I | Active |
| Nti | 863-016TSC-FG | FDA UDI | Class I | Active |
| Nti | 849-009M-FG | FDA UDI | Class I | Active |
| Nti | H514S-023 | FDA UDI | Class I | Active |
| Nti | H247UF-007-FG | FDA UDI | Class I | Active |
| Nti | 801-014M-FG | FDA UDI | Class I | Active |
| Nti | H48L-012-FG | FDA UDI | Class I | Active |
| Nti | H31R-010-HP | FDA UDI | Class I | Active |
| Nti | 836KR-010C-FG | FDA UDI | Class I | Active |
| Nti | 879K-012SC-FG | FDA UDI | Class I | Active |
| Nti | H31-012-HP | FDA UDI | Class I | Active |
| Nti | 180.15.050 | FDA UDI | Class I | Active |
| Nti | 877K-014TSC-FG | FDA UDI | Class I | Active |
| Nti | H31-010-FGM | FDA UDI | Class I | Active |
| Nti | 877K-014M-FG | FDA UDI | Class I | Active |
| Nti | HF129QSF-023 | FDA UDI | Class I | Active |
| Nti | 134-014F-FG | FDA UDI | Class I | Active |
| Nti | 837L-014TSC-FG | FDA UDI | Class I | Active |
| Nti | KS1T-FG | FDA UDI | Class I | Active |
| Nti | 862-012C-FG | FDA UDI | Class I | Active |
| Nti | H7-006-FG | FDA UDI | Class I | Active |
| Nti | H375-014-FG | FDA UDI | Class I | Active |
| Nti | 868A-021M-FG | FDA UDI | Class I | Active |
| Nti | 379-023SC-FG | FDA UDI | Class I | Active |
| Nti | 180.19.110 | FDA UDI | Class I | Active |
| Nti | 835-010SC-FG | FDA UDI | Class I | Active |
| Nti | 805-018M-HP | FDA UDI | Class I | Active |
| Nti | 878K-023SC-FG | FDA UDI | Class I | Active |
| Nti | HF364FE-023 | FDA UDI | Class I | Active |
| Nti | 837KR-014M-FG | FDA UDI | Class I | Active |
| Nti | H375-016-FG | FDA UDI | Class I | Active |
| Nti | 850W-018TSC-FG | FDA UDI | Class I | Active |
| Nti | 885-012M-FG | FDA UDI | Class I | Active |
| Nti | 845KR-016C-FG | FDA UDI | Class I | Active |
| Nti | 837-012SC-FG | FDA UDI | Class I | Active |
| Nti | HF138CE-023 | FDA UDI | Class I | Active |
| Nti | G5023 | FDA UDI | Class I | Active |
| Nti | 862-018C-FG | FDA UDI | Class I | Active |
| Nti | 837-016C-FG | FDA UDI | Class I | Active |
| Nti | 862-012SC-FG | FDA UDI | Class I | Active |
| Nti | 818-050M-HP | FDA UDI | Class I | Active |
| Nti | H21-010-FG | FDA UDI | Class I | Active |
| Nti | 847-014TSC-FG | FDA UDI | Class I | Active |
| Nti | 808-018M-HP | FDA UDI | Class I | Active |
| Nti | D911H-190 | FDA UDI | Class I | Active |
| Nti | 878K-018SC-FG | FDA UDI | Class I | Active |
| Nti | 801-018M-FG | FDA UDI | Class I | Active |
| Nti | 879-016C-FG | FDA UDI | Class I | Active |
| Nti | 180.19.150 | FDA UDI | Class I | Active |
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