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Sign in to claim this brandMedentika GmbH
Germany·DE-MF-000009117
Last updated September 17, 2026
What Medentika GmbH makes
Medentika GmbH produces dental implant components, including preformed permanent and temporary suprastructures, reusable and single-use implant analogs, and intraoral-scanning abutment analogs. Their portfolio also covers reusable surgical tools like drill guides and screwdrivers, as well as analogs for dental prostheses and implant abutment screws.
The company’s devices are classified under EU Class I and Class II regulations, with several listed in the FDA’s Unique Device Identifier (UDI) database. Medentika GmbH 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 Medentika GmbH manufacture?
Medentika GmbH specializes in dental implant components. Their portfolio includes preformed permanent and temporary suprastructures for dental implants, reusable and single-use implant analogs, and intraoral-scanning abutment analogs. Additionally, they produce reusable surgical tools such as drill guides and screwdrivers, as well as analogs for dental prostheses and implant abutment screws. These devices are designed to support dental restoration and implantology procedures.
Where is Medentika GmbH based?
Medentika GmbH is headquartered in Germany. The company’s location in Germany aligns with European regulatory standards, which may influence the classification and compliance requirements for their devices.
Which regulatory registries list Medentika GmbH’s devices?
Some of Medentika GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the United States, ensuring traceability and compliance with regulatory requirements. Listing in the UDI database does not imply approval but provides transparency for authorized devices.
How are Medentika GmbH’s devices classified under EU regulations?
Medentika GmbH’s devices are classified under EU Class I and Class II regulations. The classification depends on factors like the device’s risk level, intended use, and potential health impact. For example, reusable surgical tools like screwdrivers may fall under Class I due to lower risk, while certain implant analogs or suprastructures could be classified as Class II due to their role in critical dental procedures. Classification determines the regulatory pathway and compliance requirements for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 8-10, Hammweg , Hügelsheim, Germany
- Website
- www.medentika.de
- —
- —
- [email protected]
- Phone
- +49 7229 69912 10
- PRRC Contact
- Alexandra Schulz
- EUDAMED SRN
- DE-MF-000009117
- FDA FEI Number
- 3008770646
- DUNS Number
- 537555497
Catalogue (3532)
Page 5 of 71| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medentika | LX 61 | FDA UDI | Class II | Active |
| Medentika | I 1520 | FDA UDI | Class II | Active |
| MEDENTiKA | I 9010-ST | FDA UDI | Class II | Active |
| MEDENTiKA | S 66 | FDA UDI | Class II | Active |
| MEDENTiKA | L 8502 | FDA UDI | Class II | Active |
| MEDENTiKA | E 220-1 | FDA UDI | Class II | Active |
| MEDENTiKA | E 2120 | FDA UDI | Class II | Active |
| MEDENTiKA | EV 61 L | FDA UDI | Class I | Active |
| MEDENTiKA | E 210-1 | FDA UDI | Class II | Active |
| MEDENTiKA | I 4610 | FDA UDI | Class II | Active |
| MEDENTiKA | Y 4400 | FDA UDI | Class II | Active |
| MEDENTiKA | N 2910 | FDA UDI | Class II | Active |
| Medentika | E 9030 | FDA UDI | Class II | Active |
| MEDENTiKA | N 8020 | FDA UDI | Class II | Active |
| MEDENTiKA | C 62 L-ET | FDA UDI | Class I | Active |
| Medentika | 6-09-59V4 | FDA UDI | Class I | Active |
| Medentika | LX 1400-SB | FDA UDI | N/A | Active |
| Medentika | LX 80-ET | FDA UDI | Class I | Active |
| MEDENTiKA | Y 61 | FDA UDI | Class II | Active |
| MEDENTiKA | K 9120 | FDA UDI | Class I | Active |
| MEDENTiKA | S 3500 | FDA UDI | Class II | Active |
| MEDENTiKA | L 3510 | FDA UDI | Class II | Active |
| Medentika | F 603-ET | FDA UDI | Class II | Active |
| MEDENTiKA | R 9020-16R | FDA UDI | Class II | Active |
| MEDENTiKA | N 4900 | FDA UDI | Class I | Active |
| MEDENTiKA | T 9005-R | FDA UDI | Class II | Active |
| MEDENTiKA | F 100 | FDA UDI | Class II | Active |
| MEDENTiKA | CX 80 | FDA UDI | Class I | Active |
| MEDENTiKA | N 2420 | FDA UDI | Class II | Active |
| MEDENTiKA | L 4600 | FDA UDI | Class II | Active |
| MEDENTiKA | R 8012 | FDA UDI | Class II | Active |
| MEDENTiKA | C 82-ET | FDA UDI | Class II | Active |
| MEDENTiKA | BS 40 RK | FDA UDI | Class I | Active |
| MEDENTiKA | H 8513 | FDA UDI | Class I | Active |
| MEDENTiKA | E 1020-ET | FDA UDI | Class II | Active |
| MEDENTiKA | R 2320 | FDA UDI | Class II | Active |
| MEDENTiKA | L 4820 | FDA UDI | Class II | Active |
| MEDENTiKA | L 8501 | FDA UDI | Class II | Active |
| MEDENTiKA | E 40 RK | FDA UDI | Class I | Active |
| MEDENTiKA | L 2700-2 | FDA UDI | Class II | Active |
| MEDENTiKA | R 31 | FDA UDI | Class I | Active |
| MEDENTiKA | R 420 | FDA UDI | Class II | Active |
| Medentika | L 68 | FDA UDI | Class II | Active |
| MEDENTiKA | S 300 | FDA UDI | Class II | Active |
| MEDENTiKA | N 50 | FDA UDI | Class I | Active |
| MEDENTiKA | NE 40 RT | FDA UDI | Class I | Active |
| MEDENTiKA | N 2510 | FDA UDI | Class II | Active |
| MEDENTiKA | N 51-40 | FDA UDI | Class I | Active |
| MEDENTiKA | T 1620-1SFET | FDA UDI | Class II | Active |
| MEDENTiKA | F 210-2-3 | FDA UDI | Class II | Active |
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