Data / Medical devices / Germany / Hager & Meisinger GMBH
Hager & Meisinger GMBH: FDA-registered device maker in NEUSS North Rhine-Westphalia, Germany, 13 510(k) clearances
Hager & Meisinger GMBH is registered with the FDA (registration 8010516) in NEUSS North Rhine-Westphalia, Germany. It lists 22 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 29, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010516
- FEI number
- 3004169071
- Address
- Hansemannstrasse 10, NEUSS North Rhine-Westphalia, Germany, D-41468
- Owner or operator
- HAGER & MEISINGER GMBH (8010516)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 17, 1997
- Registered through
- 2026
- Brand names listed
- Angled Abutments OKTAGON Bone Level, BONE MANAGEMENT, Benex Twist Drills, Dental Implant Abutment OKTAGON, Dental Implant OKTAGON, Dental Implants OKTAGON Bone Level Tapered Design, Endo-Extractor, Gingiva Cutters and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | DZL | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| October 17, 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | DZL | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| October 8, 2021 | K201210 | The Micro Screw System, Micro Screw System Basic | DZL | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| August 9, 2018 | K173819 | MyPlant II Implant System | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| May 10, 2018 | K180360 | OKTAGON Implant System | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| May 24, 2017 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| February 24, 2017 | K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| November 21, 2016 | K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | NHA | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| August 31, 2015 | K143539 | Dental Implant OKTAGON Bone Level | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| July 7, 2014 | K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE | NHA | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| June 13, 2014 | K122807 | DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| February 14, 2014 | K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | DZL | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
| August 13, 2013 | K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | DZL | Substantially Equivalent | Hager& Meisinger GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 15, 2020 | 86147 | Class II | Terminated | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, | US-dates between the product package label and the bar code display. | accessdata.fda.gov |
| November 7, 2018 | 83776 | Class II | Ongoing | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm: | Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Screw, Fixation, Intraosseous
- All makers of Point, Abrasive
- All makers of Forceps, Tooth Extractor, Surgical
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Burr, Orthopedic
Updated September 29, 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.