Hager & Meisinger GmbH
NEUSS North Rhine-Westphalia, DE
HAGER & MEISINGER GMBH appears in FDA device records in NEUSS North Rhine-Westphalia, DE. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Hager & Meisinger GmbH between 2007 and 2025. The busiest year on record is 2014, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | DZL | Substantially Equivalent | |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | DZL | Substantially Equivalent | |
| K201210 | The Micro Screw System, Micro Screw System Basic | DZL | Substantially Equivalent | |
| K173819 | MyPlant II Implant System | DZE | Substantially Equivalent | |
| K180360 | OKTAGON Implant System | DZE | Substantially Equivalent | |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | DZE | Substantially Equivalent | |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | DZE | Substantially Equivalent | |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | NHA | Substantially Equivalent | |
| K143539 | Dental Implant OKTAGON Bone Level | DZE | Substantially Equivalent | |
| K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE | NHA | Substantially Equivalent | |
| K122807 | DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | DZL | Substantially Equivalent | |
| K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | DZL | Substantially Equivalent | |
| K062130 | MEISINGER BENEX, MODEL BE001 | EMG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010516 | 3004169071 | HAGER & MEISINGER GMBH | HANSEMANNSTRASSE 10, NEUSS North Rhine-Westphalia D-41468 DE | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EGGAttachment, Precision, All
- LYSBone Mill
- EJLBur, Dental
- EQJBur, Ear, Nose And Throat
- GFFBur, Surgical, General & Plastic Surgery
- HTTBurr, Orthopedic
- OFYDental Implant Surgical Tray
- DZADrill, Dental, Intraoral
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- EKSFile, Pulp Canal, Endodontic
- EMGForceps, Tooth Extractor, Surgical
- DZEImplant, Endosseous, Root-Form
- DZPInstrument, Diamond, Dental
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- DZNInstruments, Dental Hand
- HWMOsteotome
- EHLPoint, Abrasive
- DZLScrew, Fixation, Intraosseous
- EHMStrip, Polishing Agent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2937-2020 | 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, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. | US-dates between the product package label and the bar code display. | Class II | Terminated | |
| Z-0493-2020 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain