Hager & Meisinger Gmbh

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2937-2020Class IISINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 -July 15, 2020
Z-0493-2020Class IISingles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUNNovember 7, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)September 29, 2025
K240321MP Pin flat without thread (36BMP000020/MP20)October 17, 2024
K201210The Micro Screw System, Micro Screw System BasicOctober 8, 2021
K173819MyPlant II Implant SystemAugust 9, 2018
K180360OKTAGON Implant SystemMay 10, 2018
K170287Dental Implants OKTAGON Bone Level Tapered DesignMay 24, 2017
K162073Dental Implants OKTAGON Tissue Level and Bone LevelFebruary 24, 2017
K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NCNovember 21, 2016
K143539Dental Implant OKTAGON Bone LevelAugust 31, 2015
K132214ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLIDJuly 7, 2014
K122807DENTAL IMPLANT SYSTEMJune 13, 2014
K132212DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONALFebruary 14, 2014
K130682MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KITAugust 13, 2013
K062130MEISINGER BENEX, MODEL BE001April 16, 2007