Manufacturer registered with FDA
COLTENE Holding AG
ALTSTAETTEN, Switzerland. Lists 11 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 11
- Brands and models
- 36
- 510(k) clearances
- 12003–2003
- Markets registered in
- 357 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name COLTENE Holding AG 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 | COLTENE Holding AG | 1 clearances | 2003–2003 | Below |
| Canada | Health Canada | Registration holder | COLTENE/WHALEDENT GMBH & CO. KG | 43 | 2002–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Coltene/Whaledent GmbH & Co KG | 14 | 2004–2025 | 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 COLTENE Holding AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | HyFlex Guttapercha PointsHygenic Gutta Percha PointsMicroMega Guttapercha PointsROEKO GuttaFlowROEKO GuttaFlow 2ROEKO Guttapercha Points | 1983 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | CanalPro CalciSealROEKO GuttaFlowROEKO GuttaFlow 2 | 2008 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | ROEKO Gutta Flow® 2 Accessories (Mixing tips) | 2005 |
| Articulation PaperEFH · Class 1 | — | Maker | HANEL Articulating paperHANEL Foil DispenserHANEL OccluFoil+HANEL Occlusion FoilHANEL Shimstock Foil | 1997 |
| Roll CottonEFN · Class 1 | — | Maker | Luna GoldREOKO ComprecapROEKO Comprecap (anatomic)ROEKO Cotton PelletsROEKO Cotton-rollROEKO LunaROEKO LunamatROEKO ParotimatROEKO ParotisrollROEKO Roll-o-mat 2 moreROEKO Solomat-ClickROEKO Solomat-N | 1992 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Alpen Steel separating strips | 2025 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | CanalPro Color Syringes | 2019 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | HySolate Flexi Dam | 1996 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | HyFlex Paper PointsHygenic(HYG) Paper Points (PP), HYG Absorbent PP, Hygenic Spectra Points Absorbent PP, HYG Steri-I-Cell PPMicroMega Paper PointsROEKO Paper Points | 1992 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | HyFlex CM, HyFlex EDM | 2015 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | CanalPro X-Move | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
COLTENE Holding AG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Mediclus Co., Ltd (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jan 2024 | K232182 | One-Fil | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COLTENE/WHALEDENT GMBH & CO. KGFDA reg. 8010629 | LANGENAU Baden-Wurttemberg, Germany | Contract manufacturer, Foreign exporter, Manufacturer |
Other names on FDA records
Coltene/Whaledent GmbH & Co. KG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9047609). 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.