Atlas FDA

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

Friadent GmbH — Predicate Candidate Screening

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

81 daysmedian FDA review time
209 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040170FRIADENT PLUS DENTAL IMPLANT SYSTEMSFriadent GmbH2004-10-272750
K041509ANKYLOS DENTAL IMPLANT SYSTEMFriadent GmbH2004-08-26800
K040946ANKYLOS DENTAL IMPLANT SYSTEMFriadent GmbH2004-07-01800
K032302XIVE TG ABUTMENTSFriadent GmbH2003-10-02690
K032158XIVE DENTAL IMPLANT SYSTEM MULTIPLEFriadent GmbH2003-08-14300
K031674MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEMFriadent GmbH2003-08-14760
K032284XIVE TG DENTAL IMPLANT SYSTEMFriadent GmbH2003-08-14210
K024004XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEMFriadent GmbH2003-03-03890
K023799FRIOS ALGIPOREFriadent GmbH2003-02-05830
K021318XIVE DENTAL IMPLANT SYSTEMFriadent GmbH2002-07-02680
K013067FRIALOC DENTAL IMPLANT SYSTEMFriadent GmbH2002-04-092090
K013867XIVE DENTAL IMPLANT SYSTEMFriadent GmbH2002-03-151140
K013438FRIALIT-2 ESTHETICBASE ABUTMENTFriadent GmbH2001-12-20640
K994174FRIALIT-2 MH-2 ABUTMENTFriadent GmbH2000-04-201320
K994376FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATFriadent GmbH2000-03-24880
K994298FRIOS MICROSAWFriadent GmbH2000-02-18590
K993560FRIALIT-2 BONE PROFILERFriadent GmbH2000-01-10810
K993095FRIALIT-2 SELECT COMPONENTSFriadent GmbH1999-12-09840

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