Manufacturer registered with FDA
Gebr. Brasseler GmbH & Co. KG
LEMGO, Germany. Lists 24 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 24
- Brands and models
- 31
- 510(k) clearances
- 12007–2007
- Markets registered in
- 17741 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 17 markets
Where regulators' registries name Gebr. Brasseler 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 | Gebr. Brasseler GmbH & Co. KG | 1 clearances | 2007–2007 | Below |
| South Korea | MFDS | Manufacturer | GEBR. BRASSELER GmbH & Co. KGGebr.Brasseler GmbH & Co.KG · Gebr. Brasseler Gmbh & Co. KG · +2 | 210 | 1998–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | GEBR. BRASSELER GMBH & CO KG | 180 | 2006–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Gebr. Brasseler GmbH & Co. KG | 118 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Gebr Brasseler GmbH & Co KG | 56 | 2005–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GEBR. BRASSELER GMBH & CO. KGGEBR BRASSELER GMBH & CO. KG | 41 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GEBR. BRASSELER GMBH & CO. KG | 26 | 2007–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GEBR. BRASSELER GMBH & CO. KGGEBR BRASSELER GMBH & CO KG · GEBR BRASSELER GMBH & CO. KG | 25 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Gebr. Brasseler GmbH & Co. KG | 23 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GEBR.BRASSELER GmbH & Co.KGGEBR, BRASSELER GmbH & Co, KG · GEBR. BRASSELER GmbH & Co. KG | 16 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Gebr. Brasseler GmbH & Co. KG | 15 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Gebr. Brasseler GmbH & Co. KG | 13 | 2025–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Gebr. Brasseler GmbH & Co. KG | 7 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Gebr. Brasseler GmbH & Co. KGGebr. Brasseler GmbH & Co KG · Gebr. Brasseler Gmbh & Co. KG | 6 | — | Pure Global AI |
| China | NMPA | Registration holder | 博拉瑟勒有限公司Gebr. Brasseler GmbH & Co. KG | 3 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Gebr. Brasseler GmbH & Co. KG, | 1 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GEBR. BRASSELER GmbH & Co. KG | 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 Gebr. Brasseler 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 |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | KOMET OSCILLATING CONTRA-ANGELKOMET SONIC HANDPIECEW&H, Synea, Oscillating Contra Angle | 2009 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | D-PACK HEATING TIPSEndoPilot²Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-EObtura Needle Lock Nuts, Thermal Protectors, Applicator Needles, | 2005 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | KOMET BioRepairKOMET BioSealKometSeal | 2020 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment Retrieval Kit | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | KOMET CERADRILLKOMET DENTAL STEEL BURS, KOMET DENTAL TUNGSTEN CARBIDE BURS, KOMET DENTAL CERAMIC BURS, SHANK EXTENSION | 1981 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | EndoPilot²EnDrive | 2021 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | KOMET INTRAORAL DENTAL DRILL | 2006 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | KOMET BONE CUTTING INSTRUMENT AND ACCESSORY | 2010 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | KOMET DENTAL DIAMOND INSTRUMENTS | 1981 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | KOMET ABRASIVE DISK | 1981 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | KOMET ABRASIVE POINT | 1981 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | KOMET POLISHING STRIP | 2006 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Komet BioSeal Flex Tips | 2021 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS | 2007 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | KOMET ROOT CANAL SPREADER, NERVE BROACHES | 2006 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | KOMET GUTTAPERCHA | 2013 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | KOMET PAPER POINTS | 2013 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | KOMET ENDODONTIC ROOT CANAL REAMER | 2005 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE | 2005 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | EndoPilot² | 2021 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | KOMET ROOT CANAL POST | 2005 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | — | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Steel Bur / Shaping Drill | 2009 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2021 |
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
Gebr. Brasseler GmbH & Co. KG 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: Advanced Technology Research (A.T.R.) S.R.L. (1), Schlumbohm GmbH & Co. KG (1), NuSmile, Ltd. (1), Angelus Industria DE Produtos Odontologicos S/A (1), W&H Dentalwerk Bürmoos GmbH (1), W&H Dentalwerk Buermoos GmbH (1), Young O/S, LLC (1), Meta Biomed Co, Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Aug 2025 | K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | EKX Ac-Powered Direct Drive Handpiece |
| 13 Apr 2021 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | ELC Ultrasonic Scaler |
| 11 Jan 2019 | K181917 | MTA2.3 MATERIALS | NuSmile, Ltd. | KIF Root Canal Filling Resin |
| 31 Aug 2018 | K180185 | BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A | KIF Root Canal Filling Resin |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 30 Jun 2009 | K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | W&H Dentalwerk Buermoos GmbH | EFB Dental Air-Powered Handpiece |
| 1 Dec 2004 | K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | EKR Endodontic Root Canal Plugger |
| 24 Nov 2004 | K042769 | ADSEAL ROOT CANAL SEALER | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |
| 25 Aug 1995 | K944714 | W&H CORSAIR SCALER | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GEBR. BRASSELER GMBH & CO. KGFDA reg. 8010468 | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010468). 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.