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

Medentika GmbH — Predicate Candidate Screening

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

239 daysmedian FDA review time
560 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253341Custom Abutments ASMedentika GmbH2025-12-23840
K242542Medentika CAD/CAM AbutmentsMedentika GmbH2025-04-222390
K223113Medentika Abutment System, Medentika CAD/CAM Abutments, MedeMedentika GmbH2024-04-155600
K201711CARES Screw - Retained Bars and Bridges (SRBB)Medentika GmbH2020-12-081680
K200906MINICONE ImplantMedentika GmbH2020-10-161930
K191123Multi-unit AbutmentsMedentika GmbH2020-01-062520
K180564Medentika Abutment System, Medentika CAD/CAM Abutments, MedeMedentika GmbH2019-01-073080
K170838Medentika CAD/CAM TiBasesMedentika GmbH2017-09-151780
K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015-10-232670
K142167MEDENTIKA ABUTMENT SYSTEMMedentika GmbH2015-02-201980

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