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

Ab Ardent — Predicate Candidate Screening

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

77 daysmedian FDA review time

148 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K131753	MERIDIAN	Ab Ardent	2013-11-14	153
K040465	LATIT FLOW	Ab Ardent	2004-07-20	148
K022971	MICROHYBRID 11	Ab Ardent	2002-11-25	80
K022974	MICROHYBRID 12	Ab Ardent	2002-11-22	77
K022975	ETCHING 15	Ab Ardent	2002-11-22	77
K022973	ADHESIVE 14	Ab Ardent	2002-11-22	77
K022972	MICROFILL 13	Ab Ardent	2002-11-22	77
K020452	HIGH SILVER CONVENTIONAL	Ab Ardent	2002-05-07	85
K011801	FUTURA TOPCAP NON GAMMA-2	Ab Ardent	2001-08-16	69
K991974	FUTURA GLASS IONOMER SILVER REINFORCED	Ab Ardent	1999-09-17	98
K982460	VIVACAP HR	Ab Ardent	1998-08-24	40
K982458	VIVALLOY HR	Ab Ardent	1998-08-24	40
K982456	AMALCAP PLUS	Ab Ardent	1998-08-24	40

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