Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Hager& Meisinger GmbH · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

258 daysmedian FDA review time
521 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbH2025-09-292550
K240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH2024-10-172580
K201210The Micro Screw System, Micro Screw System BasicHager& Meisinger GmbH2021-10-085210
K173819MyPlant II Implant SystemHager& Meisinger GmbH2018-08-092340
K180360OKTAGON Implant SystemHager& Meisinger GmbH2018-05-10900
K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH2017-05-241140
K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH2017-02-242120
K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental ImplanHager& Meisinger GmbH2016-11-213060
K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH2015-08-312590
K132214ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM Hager& Meisinger GmbH2014-07-073560
K122807DENTAL IMPLANT SYSTEMHager& Meisinger GmbH2014-06-136520
K132212DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYHager& Meisinger GmbH2014-02-142130
K130682MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISIHager& Meisinger GmbH2013-08-131530
K062130MEISINGER BENEX, MODEL BE001Hager& Meisinger GmbH2007-04-162640

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda