Manufacturer registered with FDA
A. Handte Medizintechnik GmbH & Co. KG
TUTTLINGEN, Germany. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name A. Handte Medizintechnik GmbH & Co. KG 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 | A. Handte Medizintechnik GmbH & Co. KG | 10 device types | — | Below |
| South Korea | MFDS | Manufacturer | A. Handte Medizintechnik GmbH & Co. KG | 4 | 2021–2026 | 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 A. Handte Medizintechnik GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | — | 1978 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 1978 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | — | 1978 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| A.HANDTE MEDIZINTECHNIK GMBH & CO. KGFDA reg. 8010155 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010155). 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.