Hager & Meisinger Gmbh
FDA Regulatory Profile
Hager & Meisinger Gmbh appears in FDA public data with 2 recalls, 14 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2937-2020, Class II) was initiated on July 15, 2020. Its most recent 510(k) clearance was granted on September 29, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2937-2020 | Class II | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - | July 15, 2020 |
| Z-0493-2020 | Class II | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN | November 7, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | September 29, 2025 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | October 17, 2024 |
| K201210 | The Micro Screw System, Micro Screw System Basic | October 8, 2021 |
| K173819 | MyPlant II Implant System | August 9, 2018 |
| K180360 | OKTAGON Implant System | May 10, 2018 |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | May 24, 2017 |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | February 24, 2017 |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | November 21, 2016 |
| K143539 | Dental Implant OKTAGON Bone Level | August 31, 2015 |
| K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID | July 7, 2014 |
| K122807 | DENTAL IMPLANT SYSTEM | June 13, 2014 |
| K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | February 14, 2014 |
| K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | August 13, 2013 |
| K062130 | MEISINGER BENEX, MODEL BE001 | April 16, 2007 |