Manufacturer registered with FDA
NTI Kahla GmbH Rotary Dental Instruments
KAHLA, Germany. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 47
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1297 registrations outside the US
- Establishments
- 1Germany
Registered in 12 markets
Where regulators' registries name NTI Kahla GmbH Rotary Dental Instruments 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 | NTI Kahla GmbH Rotary Dental Instruments | 5 device types | — | Below |
| Canada | Health Canada | Registration holder | NTI-KAHLA GMBH ROTARY DENTAL INSTRUMENTS | 35 | 2007–2007 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NTI Kahla GmbH Rotary Dental Instruments | 24 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NTI KAHLA GMBH ROTARY DENTAL INSTRUMENTSNTI-KAHLA GMBH, ROTARY DENTAL INSTRUMENTS · NTI-KAHLA GMBH ROTARY DENTAL INSTRUMENTS | 10 | 2005–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | NTI Kahla GmbH Rotary Dental Instruments | 8 | 2004–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NTI-Kahla GmbH - Rotary Dental InstrumentsNTI-KAHLA GMBH ROTARY DENTAL INSTRUMENTS | 5 | 2009–2019 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | NTI-Kahla GmbH Rotary Dental Instruments | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | NTI-Kahla GmbH Rotary Dental InstrumentsNTI Kahla GmbH Rotary Dental Instruments | 4 | 2007–2012 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | NTI - Kahla GmbH Rotary Dental Instruments | 3 | 2024–2025 | Pure Global AI |
| China | NMPA | Registration holder | 恩提艾公司-牙科旋转器械NTI-Kahla GmbH Rotary Dental Instruments | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | NTI-Kahla GmbH Rotary Dental Instruments | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | NTI - Kahla GmbH Rotary Dental Instruments | 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 NTI Kahla GmbH Rotary Dental Instruments currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | NTINTI Endo Root facersNTI Gates Glidden drillsNTI Peeso reamersNTI T Endo Drill | 1995 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | All Ceramic SupermaxBambino SeriesBrix Diamond DiscBrix HP diamondInterflex diamond discKS SeriesMADC bursnano prepNTINTI Axial Reduction Bur 16 moreNTI diamond stripNTI Easy Chamfer DiamondsNTI Guide Pin DiamondNTI Handpiece Crown CutterNTI InPrep DiamondsNTI LazyBurNTI ProxyStripNTI serrated diamond stripNTI Sintered HPNTI SupermaxSuperflex diamond discT.D.F. SeriesTurbo crown cuttersTurbo diamond discsTurbo diamonds2 grit diamonds | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | NTINTI Soft Tissue TrimmerNTI Tri-FissureT&F CarbidesTDF Series | 1996 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | CeraGlazeDiaGlossGoldstarNTINTI CeraShine DuoNTI CeraShine TrioNTI CeraSuperGlazeNTI SoftMat WheelUNIVERSAL POLISHERS | 1997 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Achromat fiber postNTI | 2006 |
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 |
|---|---|---|
| NTI-KAHLA GMBH, ROTARY DENTAL INSTRUMENTSFDA reg. 9681565 | KAHLA Thuringia, Germany | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9022916). 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.