Data / Medical devices / Germany / Ot Medical GMBH
Ot Medical GMBH: FDA-registered device maker in Bremen, Germany, 3 510(k) clearances
Ot Medical GMBH is registered with the FDA (registration 3008496301) in Bremen, Germany. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 13, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008496301
- Address
- Am Tabakquartier 62, Bremen, Germany, 28197
- Owner or operator
- OT medical GmbH (10033109)
- Roles
- Manufacturer
- First device listed
- July 13, 2010
- Registered through
- 2026
- Brand names listed
- 4plus6Line Abutment, Bone Tap, Bone Trephine, Center Punch, Cortical Drill, CreativeLine, Depth Gauge 2, Final drill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2016 | K151608 | 4plus6Line Abutment System | NHA | Substantially Equivalent | Ot Medical GmbH | accessdata.fda.gov |
| November 5, 2015 | K151432 | NaturalLine Abutment | NHA | Substantially Equivalent | Ot Medical GmbH | accessdata.fda.gov |
| November 16, 2012 | K113113 | ENDOSSEOUS DENTAL IMPLANT | DZE | Substantially Equivalent | Ot Medical GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Bur, Dental
- All makers of Handle, Instrument, Dental
- All makers of Gauge, Depth, Instrument, Dental
Updated April 13, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.