Manufacturer registered with FDA
Hager& Meisinger GmbH
NEUSS, Germany. Lists 14 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 134
- 510(k) clearances
- 142007–2025
- Markets registered in
- 151,253 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Hager& Meisinger GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hager& Meisinger GmbH | 14 clearances | 2007–2025 | Below |
| Canada | Health Canada | Registration holder | HAGER & MEISINGER GMBH | 777 | 2007–2025 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | Hager & Meisinger GmbH | 138 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hager & Meisinger GmbH | 78 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hager & Meisinger GmbH | 76 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Hager & Meisinger GmbH | 49 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HAGER & MEISINGER GMBHHager & Meisinger GmbH | 36 | 2006–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hager & Meisinger GmbHHager&Meisinger GmbH · Hager & Meisinger GmbH. · +2 | 27 | 1999–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HAGER & MEISINGER GMBH | 22 | 2011–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Hager & Meisinger GmbH | 15 | 2009–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HAGER & MEISINGER GMBHHAGER & MEISINGER GMBH. | 12 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Hager & Meisinger GmbHHager and Meisinger GmbH | 10 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Hager & Meisinger GmbH | 6 | 2025–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HAGER & MEISINGER GmbHHager & Meisinger GmbH | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 哈戈梅森格有限公司 Hager & Meisinger GmbH哈戈梅森格有限公司Hager & Meisinger GmbH | 2 | — | 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 Hager& Meisinger GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Dental Implant OKTAGONDental Implants OKTAGON Bone Level Tapered Designmyplant two Abutmentmyplant two Ball Anchormyplant two Cover Screwmyplant two Dental Implantmyplant two Healing Abutmentmyplant two Healing Capmyplant two Occlusal Screwmyplant two Screw for Ceramics 5 moremyplant two Shoulder AbutmentOKTAGON Bone Level and Tissue Level Implant VariationsOKTAGON Bone Level ImplantsOKTAGON Implant SystemOKTAGON Prosthetic Parts | 2014 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Master Pin Control (Basic)Master-Pin XMeisinger Dental Bone ScrewMeisinger Tacs and PinsMicro Screw System, Micro Screw System BasicMP Pin without thread, flat headScrew System TX (Professional) | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Angled Abutments OKTAGON Bone LevelDental Implant Abutment OKTAGONmyplant two Abutmentmyplant two Ball Anchormyplant two Cover Screwmyplant two Dental Implantmyplant two Healing Abutmentmyplant two Healing Capmyplant two Occlusal Screwmyplant two Screw for Ceramics 6 moremyplant two Shoulder AbutmentOKTAGON Bone Level ImplantsOKTAGON Implant SystemOKTAGON Plastic CopingOKTAGON Plastic ShoulderOKTAGON Prosthetic Parts | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Benex Twist DrillsMEI CTMEI GlideMEI K-FilesMEI LegendMEI ReamersMEI SequenceMEI StormMEI TaperMEI Wave 7 moreMeisinger Endo Access BursMeisinger Munce BursMeisinger Pulp Chamber BursMeisinger Rotary Root Canal BursMeisinger Twist DrillsOKTAGON Drill ExtensionOKTAGON Twist drills | 2002 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Hand WheelMeisinger Bone Ring TweezerMeisinger Bone ScraperMeisinger ChiselMeisinger CuretteMeisinger Dental Hand ToolsMeisinger ForcepsMeisinger Mirror HandleMeisinger Needle HolderMeisinger Scalpell Handle 4 moreMeisinger ScissorsOKTAGON Depth GaugeOKTAGON Direction IndicatorOKTAGON Parallel Pin | 2017 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | MEISINGER Diamond InstrumentsSingles | 2002 |
| All Precision AttachmentEGG · Class 1 | — | Maker | myplant two Matrix Ball Anchormyplant two O-Ringmyplant two Taper Capmyplant two Taper Cap with Retention | 2019 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | MEISINGER Abrasives | 2002 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | MEISINGER Prophy Strips | 2002 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | MEISINGER Rotary Steel InstrumentsMEISINGER Rotary Tungsten Carbide Instrumentsmyplant two Conical Reamermyplant two Drill Extensionmyplant two Initial Burmyplant two Round Drillmyplant two Tri-Spade Drillmyplant two Twist DrillOKTAGON Pilot DrillSingles 1 moreSingles Carbide | 1997 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | MEISINGER | 2003 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Endo-ExtractorMEISINGER BENEXMeitrac Extractor | 2005 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BONE MANAGEMENTMeisinger ScrewdriverMEISINGER Spreadermyplant two Backturn Instrumentmyplant two Hand Wheelmyplant two Handle Laboratorymyplant two High Torque Adaptermyplant two Implant Analogmyplant two Laboratory Analog Ball Anchormyplant two Laboratory Analog One-Piece 27 moremyplant two Open-End Wrenchmyplant two Positioning Keymyplant two Ratchetmyplant two Repositioning Postmyplant two Revision Instrumentmyplant two Screwdrivermyplant two Seating Instrumentmyplant two Seating Instrument Ball Anchormyplant two Tapmyplant two Torque Indicatormyplant two Transfer Capmyplant two Transfer Postmyplant two Trial Abutmentmyplant two Wax-Up CopingOKTAGON Abutment AnalogOKTAGON Abutment DriverOKTAGON AdapterOKTAGON Emergency ToolOKTAGON Holding KeyOKTAGON Implant AnalogOKTAGON Impression CapOKTAGON Positioning CylinderOKTAGON ScrewdriverOKTAGON Sleeve HolderOKTAGON TapOKTAGON Torque RatchetOKTAGON X-Ray Reference Sphere | 2003 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | OKT Micro Kit 3.75 BLOKT Micro Kit 3.75 BLTOKT Micro Kit 3.75 TLOKT Surgical Kit Mini BLTOKT Surgical Kit Mini Drill Stop BLT | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hager& Meisinger GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Sep 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | DZL Intraosseous Fixation Screw |
| 17 Oct 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | DZL Intraosseous Fixation Screw |
| 8 Oct 2021 | K201210 | The Micro Screw System, Micro Screw System Basic | DZL Intraosseous Fixation Screw |
| 9 Aug 2018 | K173819 | MyPlant II Implant System | DZE Root-Form Endosseous Implant |
| 10 May 2018 | K180360 | OKTAGON Implant System | DZE Root-Form Endosseous Implant |
| 24 May 2017 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | DZE Root-Form Endosseous Implant |
| 24 Feb 2017 | K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | DZE Root-Form Endosseous Implant |
| 21 Nov 2016 | K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | NHA Endosseous Dental Implant Abutment |
| 31 Aug 2015 | K143539 | Dental Implant OKTAGON Bone Level | DZE Root-Form Endosseous Implant |
| 7 Jul 2014 | K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE | NHA Endosseous Dental Implant Abutment |
| 13 Jun 2014 | K122807 | DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Feb 2014 | K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | DZL Intraosseous Fixation Screw |
| 13 Aug 2013 | K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | DZL Intraosseous Fixation Screw |
| 16 Apr 2007 | K062130 | MEISINGER BENEX, MODEL BE001 | EMG Surgical Tooth Extractor Forceps |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HAGER & MEISINGER GMBHFDA reg. 8010516 | NEUSS North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010516). 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.