Registered with FDA
Drendel & Zweiling DIAMANT GmbH
KALLETAL, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 841 registrations outside the US
- Establishments
- 1Germany
Registered in 8 markets
Where regulators' registries name Drendel & Zweiling DIAMANT 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 | Lister | Drendel & Zweiling DIAMANT GmbH | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Drendel + Zweiling DIAMANT GmbHDrendel+Zweiling DIAMANT GmbH · DRENDEL+ZWEILING DIAMANT GMBH · +2 | 21 | 1999–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DRENDEL + ZWEILING DIAMANT GMBHDrendel + Zweiling DIAMANT GmbH | 7 | 2005–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Drendel & Zweiling DIAMANT GmbH | 4 | 2004–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Drendel + Zweiling DIAMANT GmbH | 4 | 2012–2013 | Pure Global AI |
| China | NMPA | Registration holder | 勃兰顿+兹威灵金刚砂有限公司Drendel + Zweiling DIAMANT GmbH | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Drendel + Zweiling DIAMANT GmbH | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Drendel+ Zweiling DIAMANT GmbH | 1 | — | 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 Drendel & Zweiling DIAMANT 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 |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | DENTAL DIAMONDSECOLINE | 1981 |
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 |
|---|---|---|
| Drendel + Zweiling DIAMANT GmbHFDA reg. 9611505 | Kalletal North Rhine-Westphalia, Germany | Foreign exporter, Repacker / relabeler |
Other names on FDA records
Drendel + Zweiling DIAMANT GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010579). 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.