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

American Orthodontics — Predicate Candidate Screening

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

67 daysmedian FDA review time

206 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days
K261840	BracePaste Prime Plus	American Orthodontics	2026-06-03	1
K232011	Cleo	American Orthodontics	2023-07-07	1
K202276	BracePaste Band and Build LC	American Orthodontics	2020-08-14	3
K181910	BracePaste MTP Light Cure Primer	American Orthodontics	2018-10-15	90
K172953	Acid Etchant	American Orthodontics	2018-02-06	133
K160782	BracePaste Adhesive	American Orthodontics	2016-10-14	206
K143117	Wire Sterilization Package with Indicators	American Orthodontics	2015-10-29	364
K122753	EMPOWER CLEAR	American Orthodontics	2012-12-14	98
K080749	RADIANCE	American Orthodontics	2008-08-04	140
K925012	PLASTIC CHAIN	American Orthodontics	1993-09-13	346
K922984	ORTHODONTIC BITE	American Orthodontics	1993-03-31	282
K926578	UNI-STICK PLASTIC LIGATURE, MODIFIED	American Orthodontics	1993-03-31	191
K923261	ORTHODONTIC METAL BRACKET	American Orthodontics	1992-12-03	154
K912417	MOLAR DISTALIZING ASSEMBLY	American Orthodontics	1991-12-20	203
K904128	PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER	American Orthodontics	1990-11-09	65
K902064	MODIFIED UNI-STICK PLASTIC LIGATURE	American Orthodontics	1990-08-06	90
K900488	MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE	American Orthodontics	1990-06-01	122
K896249	BANDTITE GLASS IONOMER CEMENT	American Orthodontics	1990-01-26	88
K895714	ORTHO-KEV APPLIANCE REINFORCING SYSTEM	American Orthodontics	1989-12-21	87
K895163	FORCE II	American Orthodontics	1989-10-27	66
K891331	UNI-STICK PLASTIC LIGATURES	American Orthodontics	1989-10-16	220
K893482	KORN MANDIBULAR ADVANCER	American Orthodontics	1989-10-12	161
K893655	KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK	American Orthodontics	1989-08-23	100
K893555	X-RING AND SPEED STIX PLASTIC LIGATURES	American Orthodontics	1989-07-14	67
K893483	BONDABLE RETAINER AND SPACE MAINTAINER	American Orthodontics	1989-07-14	71
K893484	MULTIPHASE ORTHODONTIC WIRE	American Orthodontics	1989-07-14	71
K893550	PLASTIC FORCE MODULE	American Orthodontics	1989-07-14	67
K893654	MEMORY CHAIN	American Orthodontics	1989-06-23	39
K893396	AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM	American Orthodontics	1989-06-23	53
K893542	DIASTEMA CLOSING KIT	American Orthodontics	1989-06-23	46
K893549	X-RING SEPARATORS	American Orthodontics	1989-06-23	46
K893255	SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE	American Orthodontics	1989-06-21	54
K893037	NO-MIX 30 ORTHODONTIC BONDING SYSTEMS	American Orthodontics	1989-06-12	49
K891775	MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES	American Orthodontics	1989-05-11	48
K891327	NICKLE-TITANIUM ORTHODONTIC WIRE	American Orthodontics	1989-05-10	61
K891599	FILAFLEX ORTHODONTIC WIRE	American Orthodontics	1989-05-02	43
K890536	JASPER JUMPER KIT	American Orthodontics	1989-05-01	87
K890656	LIP BUMPER	American Orthodontics	1989-04-17	68
K891354	ORTHODONTIC COTTON ROLL HOLDERS	American Orthodontics	1989-04-17	38
K891484	ORTHODONTIC WRAP-AROUND HAWLEY RETAINER	American Orthodontics	1989-04-14	28
K891592	ORTHODONTIC ARCH AND SURGICAL HOOKS	American Orthodontics	1989-04-07	18
K891328	PREFORMED TEMPLATE FOR TOOTH POSITIONER	American Orthodontics	1989-03-31	21
K891372	ORTHODONTIC PLASTIC BRACKET	American Orthodontics	1989-03-31	22
K890581	THE CLARK LIP SHIELD	American Orthodontics	1989-03-17	39
K890145	20/20 ORTHODONTIC CERAMIC BRACKET	American Orthodontics	1989-03-13	59

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