Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010468

FEI Number

3002806577

Entity Name

GEBR. BRASSELER GMBH & CO. KG

City/State/Country

LEMGO North Rhine-Westphalia, DE

Establishment Address

ATTN.: Petra Meier, Trophagener Weg 25, LEMGO North Rhine-Westphalia D-32657, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GEBR. BRASSELER GMBH & CO. KG (Owner Number: 8010468)

Owner / Operator Contact Address

25 TROPHAGENER WEG, LEMGO, DE-NOTA D-32657, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KOMET SONIC HANDPIECE EndoPilot² KOMET DENTAL STEEL BURS, KOMET DENTAL TUNGSTEN CARBIDE BURS, KOMET DENTAL CERAMIC BURS, SHANK EXTENSION Pedicle Screw System KOMET ABRASIVE DISK KometSeal Abutment Retrieval Kit KOMET DENTAL DIAMOND INSTRUMENTS KOMET CERADRILL KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE KOMET Driver, Surgical, Pin Obtura Needle Lock Nuts, Thermal Protectors, Applicator Needles, KOMET TRAY SURGICAL INSTRUMENT KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS Guide Pin KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY KOMET BONE CUTTING INSTRUMENT AND ACCESSORY KOMET INTRAORAL DENTAL DRILL KOMET PIN, FIXATION, SMOOTH KOMET PIN, FIXATION, THREADED KOMET SCREW, FIXATION, BONE Steel Bur / Shaping Drill KOMET ROOT CANAL SPREADER, NERVE BROACHES W&H, Synea, Oscillating Contra Angle KOMET BioSeal Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E D-PACK HEATING TIPS KOMET BioRepair EnDrive KOMET SURGICAL SAW BLADE GENERAL & PLASTIC SURGERY Cross Pin KOMET STEEL BURR FOR OPHTHALMOLOGY KOMET POLISHING STRIP Orthopaedic Steel Instrument KOMET ROOT CANAL POST KOMET ABRASIVE POINT KOMET ENDODONTIC ROOT CANAL REAMER KOMET OSCILLATING CONTRA-ANGEL Komet BioSeal Flex Tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2009-04-02
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-02-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-03-26
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2021-05-11
LQY	Locator, Root Apex	Unknown	Class U	N/A	2021-05-11
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-05-11
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2021-05-11
EJL	Bur, Dental	Dental	Class 1	872.3240	1981-08-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-02-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-02-24
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2025-04-30
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	1981-08-24
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-10-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-04-09
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1981-08-24
EJL	Bur, Dental	Dental	Class 1	872.3240	2009-04-15
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2005-10-31
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2013-12-18
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2024-01-19
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2021-10-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2006-05-30
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2007-02-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-03-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-03-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-03-08
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2005-10-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-01-20
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2010-08-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-12
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2006-08-23
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-12-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-18
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-12-18
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-02-18
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2009-04-14
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2006-05-30
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-25
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2025-06-24
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2020-10-21
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2005-10-31
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-01-17
LQY	Locator, Root Apex	Unknown	Class U	N/A	2025-12-03
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2025-12-03
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2005-09-09
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-02-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-02-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-02-19
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2010-01-12
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2006-08-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-03-10
ELR	Post, Root Canal	Dental	Class 1	872.3810	2005-10-19
EHL	Point, Abrasive	Dental	Class 1	872.6010	1981-08-24
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2005-10-31
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-05-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-07-07
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-25
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2009-07-03
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2021-06-30

Official Correspondent

Sandra Rabe

US Agent Details

Imke Lindenbeck Business: KOMET USA LLC Email: ilindenbeck@komet-usa.com Phone: (803) 3231504

Related Public Records

Same Entity

GEBR. BRASSELER GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010468. Last updated year: 2026. Please use registration number 8010468 when referencing this establishment in official correspondence.