Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010516

FEI Number

3004169071

Entity Name

HAGER & MEISINGER GMBH

City/State/Country

NEUSS North Rhine-Westphalia, DE

Establishment Address

HANSEMANNSTRASSE 10, NEUSS North Rhine-Westphalia D-41468, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HAGER & MEISINGER GMBH (Owner Number: 8010516)

Owner / Operator Contact Address

HANSEMANNSTRASSE 10, --, NEUSS, DE-NOTA D-41468, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173819

PMA Number

N/A

All Registered Proprietary Names

OKTAGON Bone Level and Tissue Level Implant Variations MEISINGER Abrasives Meisinger Dental Bone Screw Screw System TX (Professional) OKTAGON Emergency Tool OKTAGON Tap OKTAGON Abutment Driver Meisinger Screwdriver OKTAGON Positioning Cylinder OKTAGON Abutment Analog OKTAGON Screwdriver OKTAGON Adapter OKTAGON Holding Key OKTAGON X-Ray Reference Sphere OKTAGON Implant Analog OKTAGON Torque Ratchet OKTAGON Impression Cap myplant two Positioning Key myplant two Seating Instrument OKTAGON Sleeve Holder myplant two Screwdriver myplant two Tap myplant two Handle Laboratory myplant two High Torque Adapter myplant two Torque Indicator myplant two Backturn Instrument myplant two Repositioning Post myplant two Laboratory Analog Ball Anchor myplant two Revision Instrument myplant two Wax-Up Coping myplant two Laboratory Analog One-Piece myplant two Trial Abutment myplant two Transfer Post myplant two Transfer Cap myplant two Seating Instrument Ball Anchor myplant two Open-End Wrench myplant two Ratchet myplant two Implant Analog myplant two Hand Wheel BONE MANAGEMENT MEISINGER Spreader Endo-Extractor Meitrac Extractor MEISINGER BENEX MEISINGER Prophy Strips OKTAGON Twist drills MEI K-Files MEI CT MEI Glide Meisinger Munce Burs MEI Wave Meisinger Pulp Chamber Burs Meisinger Endo Access Burs MEI Sequence MEI Storm OKTAGON Drill Extension MEI Taper MEI Legend MEI Reamers Meisinger Rotary Root Canal Burs Meisinger Twist Drills Benex Twist Drills Meisinger Scissors Meisinger Curette Hand Wheel Meisinger Needle Holder Meisinger Dental Hand Tools OKTAGON Depth Gauge OKTAGON Parallel Pin OKTAGON Direction Indicator Meisinger Forceps Meisinger Scalpell Handle Meisinger Chisel Meisinger Mirror Handle Meisinger Bone Ring Tweezer Meisinger Bone Scraper OKTAGON Implant System OKT Surgical Kit Mini BLT OKT Surgical Kit Mini Drill Stop BLT OKT Micro Kit 3.75 BLT OKT Micro Kit 3.75 TL OKT Micro Kit 3.75 BL Dental Implant OKTAGON myplant two Taper Cap with Retention myplant two Matrix Ball Anchor myplant two O-Ring myplant two Taper Cap Singles Carbide Singles MEISINGER Rotary Tungsten Carbide Instruments OKTAGON Pilot Drill myplant two Tri-Spade Drill myplant two Twist Drill myplant two Initial Bur myplant two Round Drill myplant two Conical Reamer myplant two Drill Extension MEISINGER Rotary Steel Instruments Master-Pin X OSTEOTOME MEISINGER ENT Burs Dental Implant Abutment OKTAGON OKTAGON Prosthetic Parts OKTAGON Plastic Coping OKTAGON Plastic Shoulder Angled Abutments OKTAGON Bone Level myplant two Screw for Ceramics myplant two Healing Cap myplant two Abutment myplant two Dental Implant myplant two Cover Screw myplant two Healing Abutment myplant two Occlusal Screw myplant two Shoulder Abutment myplant two Ball Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-03-01
EHL	Point, Abrasive	Dental	Class 1	872.6010	2002-08-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-31
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2014-02-20
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2003-09-29
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2005-07-15
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2002-08-08
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2021-03-16
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2015-10-19
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2002-08-08
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-31
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-08-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-05-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-05-14
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-05-13
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2019-08-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-06-17
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2019-06-07
EJL	Bur, Dental	Dental	Class 1	872.3240	1997-04-17
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2025-09-30
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2007-09-07
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2003-09-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-07-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-11-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-06-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

Ethan Miller Business: Meisinger USA Email: EMiller@meisingerusa.com Phone: (303) 2685400

Related Public Records

Same Entity

HAGER & MEISINGER GMBH

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
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
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010516. Last updated year: 2026. Please use registration number 8010516 when referencing this establishment in official correspondence.