Skip to the page
Get started free

Data / Medical devices / Germany / Gebr. Brasseler GMBH & Co. KG

Gebr. Brasseler GMBH & Co. KG: FDA-registered device maker in LEMGO North Rhine-Westphalia, Germany, 11 510(k) clearances

Gebr. Brasseler GMBH & Co. KG is registered with the FDA (registration 8010468) in LEMGO North Rhine-Westphalia, Germany. It lists 50 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 22, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Gebr. Brasseler GMBH & Co. KG
FDA registration number
8010468
FEI number
3002806577
Address
ATTN.: Petra Meier Trophagener Weg 25, LEMGO North Rhine-Westphalia, Germany, D-32657
Owner or operator
GEBR. BRASSELER GMBH & CO. KG (8010468)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 24, 1981
Registered through
2026
Brand names listed
Abutment Retrieval Kit, Cross Pin, D-PACK HEATING TIPS, EnDrive, EndoPilot², Guide Pin, Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E, KOMET ABRASIVE DISK and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufactureraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Contract manufacturer, Manufactureraccessdata.fda.gov
Bur, DentalEJL1Contract manufacturer, Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract manufacturer, Manufactureraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Contract manufactureraccessdata.fda.gov
Device, Monitoring, Intracranial PressureGWM2Contract manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Drill, Bone, PoweredDZI2Contract manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Contract manufacturer, Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Contract manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Manufacturer, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Exporter to the USaccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Exporter to the US, Specification developeraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Exporter to the USaccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Contract manufactureraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Locator, Root ApexLQYUExporter to the USaccessdata.fda.gov
Orthopedic Augmented RealitySBF2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufactureraccessdata.fda.gov
Plate, BoneJEY2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Exporter to the USaccessdata.fda.gov
Point, AbrasiveEHL1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Point, Paper, EndodonticEKN1Exporter to the USaccessdata.fda.gov
Post, Root CanalELR1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Contract manufacturer, Manufactureraccessdata.fda.gov
Resin, Root Canal FillingKIF2Exporter to the US, Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Contract manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Exporter to the USaccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Specification developeraccessdata.fda.gov
Strip, Polishing AgentEHM1Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Exporter to the USaccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
WrenchHXC1Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 22, 2025K243692EnDrive (EnDriveUS)EKXSubstantially EquivalentAdvanced Technology Research (A.T.R.) S.R.L.accessdata.fda.gov
April 13, 2021K202906EndoPilot2ELCSubstantially EquivalentSchlumbohm GmbH & Co. KGaccessdata.fda.gov
January 11, 2019K181917MTA2.3 MATERIALSKIFSubstantially EquivalentNuSmile, Ltd.accessdata.fda.gov
August 31, 2018K180185BIO-C REPAIRKIFSubstantially EquivalentAngelus Industria DE Produtos Odontologicos S/Aaccessdata.fda.gov
February 23, 2017K162926Air-Powered Handpieces and Handpiece AttachmentsEFBSubstantially EquivalentW&H Dentalwerk Burmoos GmbHaccessdata.fda.gov
July 26, 2013K131264KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWSHWCSubstantially EquivalentGebr. Brasseler GmbH & Co. KGaccessdata.fda.gov
June 30, 2009K090548CONTRA-ANGLE HANDPIECE KOMET OS30EFBSubstantially EquivalentW&H Dentalwerk Buermoos GmbHaccessdata.fda.gov
June 29, 2007K071352CERADRILLEJLSubstantially EquivalentGebr. Brasseler GmbH & Co. KGaccessdata.fda.gov
December 1, 2004K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700EKRSubstantially EquivalentYoung O/S, LLCaccessdata.fda.gov
November 24, 2004K042769ADSEAL ROOT CANAL SEALERKIFSubstantially EquivalentMeta Biomed Co., Ltd.accessdata.fda.gov
August 25, 1995K944714W&H CORSAIR SCALEREFBSubstantially EquivalentA-Dec, Inc.accessdata.fda.gov

Compare with other makers

Updated August 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.