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

Lancer Orthodontics, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time

235 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K122069	STORM MINI SCREW	Lancer Orthodontics, Inc.	2013-04-11	269
K071192	BLUGOO HD	Lancer Orthodontics, Inc.	2007-06-22	53
K051552	O.A.S.I. SYSTEM	Lancer Orthodontics, Inc.	2005-09-19	98
K991481	PARAGON	Lancer Orthodontics, Inc.	1999-08-11	105
K904090	ORTHODONTIC BONDING ADHESIVE CONTROL	Lancer Orthodontics, Inc.	1991-04-29	235
K904092	LANCER ORIGINAL, SIERRA, GENERAL PURPOSE	Lancer Orthodontics, Inc.	1990-11-09	64
K904093	BUCCAL TUBE, BUCCAL ATTACHMENT	Lancer Orthodontics, Inc.	1990-11-07	62
K904091	TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO	Lancer Orthodontics, Inc.	1990-11-05	60
K904089	PERMA MESH	Lancer Orthodontics, Inc.	1990-11-02	57
K904094	C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE	Lancer Orthodontics, Inc.	1990-11-02	57
K902075	INTRIGUE CERAMIC BRACKET	Lancer Orthodontics, Inc.	1990-08-06	90
K901958	GUARDIAN SAFE BOW	Lancer Orthodontics, Inc.	1990-07-30	90
K901957	MUSTANG, C.A.T.	Lancer Orthodontics, Inc.	1990-07-30	90
K900578	SPORTS PACK ELASTICS	Lancer Orthodontics, Inc.	1990-04-10	62

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