Ormco Corp.

Glendora, CA, US

Ormco Corp. appears in FDA device records in Glendora, CA. FDA records list 27 510(k) clearances between 1985-08-29 and 1996-01-04, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 27
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 27 510(k) clearances for Ormco Corp. between 1985 and 1996. The busiest year on record is 1990, with 5. The most recent is 1996, with 1.

Clearances by year, as a table

510(k) clearance decisions for Ormco Corp., by decision year
Year	Clearances
1985	1
1986	1
1987	2
1989	4
1990	5
1991	1
1992	5
1993	2
1994	2
1995	3
1996	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K955333	SPIRIT MB	DYW	Substantially Equivalent	1996-01-04
K951239	GLOWING SPIRITS	DYW	Substantially Equivalent	1995-07-19
K951776	BAND SEATER	ECR	Substantially Equivalent	1995-05-23
K946255	THERMASET	DYH	Substantially Equivalent	1995-01-27
K943068	MAGNEFORCE	ECO	Substantially Equivalent	1994-08-17
K941015	ORMCO SYSTEM 1+ (TM)	DYH	Substantially Equivalent	1994-03-31
K922806	ORMCO SPORTSGUARD	EJF	Substantially Equivalent	1993-10-20
K923405	THE HERBST APPLIANCE	EJF	Substantially Equivalent	1993-05-05
K923556	ADP FACEMASK	DZB	Substantially Equivalent	1992-12-04
K923399	CHALLENGE II - PASTE ADHESIVE	DYH	Substantially Equivalent	1992-10-27
K921245	THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II	DYH	Substantially Equivalent	1992-05-05
K921385	IMPROVED SEQUENCE LIGHT CURE ADHESIVE	DYH	Substantially Equivalent	1992-04-21
K914727	SEQUENCE LIGHT CURE ADHESIVE	DYH	Substantially Equivalent	1992-01-17
K914616	KLEER(TM) ORTHODONTIC BRACKET	EJF	Substantially Equivalent	1991-11-20
K905197	THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM	EJT	Substantially Equivalent	1990-12-27
K902646	HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP	DZB	Substantially Equivalent	1990-09-06
K902645	HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL	DZB	Substantially Equivalent	1990-09-06
K900184	LINGUAL SHEATH	EJF	Substantially Equivalent	1990-04-02
K896913	SPIRIT	DYW	Substantially Equivalent	1990-03-08
K894781	OPTIFLEX	EJF	Substantially Equivalent	1989-09-15
K894358	LUMINA ORTHODONTIC BRACKET	EJF	Substantially Equivalent	1989-09-15
K892704	GEM II ORTHODONTIC BRACKET	EJF	Substantially Equivalent	1989-06-12
K890740	FRS LITE FLUORIDE RELEASING SEALANT	DYH	Substantially Equivalent	1989-04-25
K870536	GEM ORTHODONTIC BRACKET	EJF	Substantially Equivalent	1987-02-19
K863709	CHALLENGE ORTHODONTIC BONDING ADHESIVE	DYH	Substantially Equivalent	1987-01-21
K862538	SENTRY BREAKWAY NECK STRAP	DZB	Substantially Equivalent	1986-07-11
K852894	ORMCO TRANSMANDIBULAR IMPLANT	MDL	Unknown	1985-08-29

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain