Manufacturer registered with FDA
OT medical GmbH
Bremen, Germany. Lists 8 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 34
- 510(k) clearances
- 32012–2016
- Markets registered in
- 459 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name OT medical GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | OT medical GmbH | 3 clearances | 2012–2016 | Below |
| Canada | Health Canada | Registration holder | OT MEDICAL GMBH | 51 | 2014–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OT medical GmbH | 7 | 2011–2013 | Pure Global AI |
| Egypt | EDA | Manufacturer | OT medical GmbH, | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What OT medical GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CreativeLineNaturalLineNaturalLine AbutmentOT-F² ImplantsOT-F³ ImplantsPreformProfiLineTecLine4plus6Line Abutment | 2012 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | CreativeLineNaturalLineOT-F² ImplantsOT-F³ ImplantsProfiLineTecLine | 2012 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Gauge 2 | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | OT-F³ Osteotome Handle, bendedOT-F³ Osteotome Handle, straightOT-F³ Tip wrench | 2013 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bone TapBone TrephineCortical DrillFinal drillImplant DriverInterspace drillPilot drillPilot drill 1Pilot drill 2Prosthetic Driver | 2014 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | Center Punch | 2014 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | OT-F³ Osteotome TipOT-F³ Trial Fit Gauge | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | OT-F1, OT-F2, OT-F3, BicorticScan Body | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names OT medical GmbH as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OT MEDICAL GMBHFDA reg. 3008496301 | Bremen, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033109). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.