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Ormco Corporation

United States·US-MF-000038085

Last updated September 17, 2026

Information

Country: United States
Address: 200, S Kraemer Blvd, Brea, United States
Website: envistaco.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Procoro Herrera
EUDAMED SRN: US-MF-000038085
FDA FEI Number: 3015272949
DUNS Number: —

Catalogue (6676)

Page 17 of 134

Device	Model / Reference	Registries	Class	Status
Peerless Upper B/T 0x022x045 Ging Lt	193-0101	EUDAMEDFDA UDI	Class IIa	Active
Ling.hrt.assy.upr.cus Rt .018	367-5003	EUDAMED	Class IIa	Active
Universal Lower Second Bicuspid Band Size 29	330-0129	EUDAMEDFDA UDI	Class IIa	Active
L6l Bkt 22 Andrews T2 Pa Cap -1/-30/4	137-0209	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 2251 Andrews Mt Hk 0/-9/10	138-0079	EUDAMED	Class IIa	Active
U3r Twin Db/Mm 22 Andrews T2 Pa 14/-7/4	364-1020	EUDAMED	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 7	652-0007	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 25	374-0025	EUDAMEDFDA UDI	Class IIa	Active
U3r Attract Db/Am 18 Suptq Bhk 9/3/4	363-7004	EUDAMED	Class IIa	Active
Prls 10 Ufm Combi B/T -10trq 18x45 Rt	196-0202	EUDAMEDFDA UDI	Class IIa	Active
Burstone Tranpal Arch 32x32 Tma Pk/10	233-0001	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Ndx-20tx018	512-2204	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 24	654-0124	EUDAMEDFDA UDI	Class IIa	Active
U1l Minitwin Db/Mtwin 18 Suptq 5/17	328-0141	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 5	373-0005	EUDAMEDFDA UDI	Class IIa	Active
REVERSE CURVE NiTi DAMON 016 X 025 PK5	216-3806	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 1845 Roth Mt Hk 0/-14/14	138-0036	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 13	457-0013	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Trimline Band Size 99	487-0099	EUDAMEDFDA UDI	Class IIa	Active
Spark 20 - Single Arch	728-3021	EUDAMEDFDA UDI	Class IIa	Active
U2r Damon Q2 022 +8/+9/0 Std Tq	491-8870	EUDAMEDFDA UDI	Class IIa	Active
L4r Attract Db/Am 18 Roth -1/-17/4	363-7050	EUDAMED	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 31	332-0331	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 28	459-0128	EUDAMEDFDA UDI	Class IIa	Active
Ling Assy U/R 1 Molar Band Pd W/Hk018	367-1006	EUDAMED	Class IIa	Active
Lower Left Ultimax Band Size 21	460-0121	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 26	376-0026	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 20	479-0020	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Sws Db/Om 22 M/B Hk Andrews Non G-Off 2/-7/0	339-2540	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Bkt-Ul Lat -4.5r +9t 9a 018	454-0211	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl 2nd Wdx -10tx22 Ul	515-0211	EUDAMEDFDA UDI	Class IIa	Active
L3l Mtwn Vs Db/Mtwn 22 Roth Dbhk 7/-11/2	319-1411	EUDAMED	Class IIa	Active
Spark Unlimited - Refinement	728-3210-S	EUDAMED	Class IIa	Active
Wire 7in.0170 Dead Soft Respond Pk10	264-1170	EUDAMED	Class IIa	Active
Orthos Cm Cuniti 35arch 21x25losmpk10	219-4113	EUDAMEDFDA UDI	Class IIa	Active
L6r Db/Ul 22 Spec Mt Hk Bal 0/-10	438-0012	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Us 016 Nd Ppak 10pk	227-9043	EUDAMEDFDA UDI	Class IIa	Active
Ormco Digital Bonding Kit - DQ2 (double arch)	728-3104	EUDAMED	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 5	652-0105	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Clear .022 -9/+5/0 Lo Tq Hk	497-7483	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 18 D/G Hk Roth G-Off 2bi -1/-22/4	338-1711	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF UM 016 NiTi DIMPLE 10PK	227-3367	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 23	653-0023	EUDAMEDFDA UDI	Class IIa	Active
Spark Junior (phase 1) - Dual Arch	728-3220-D	EUDAMED	Class IIa	Active
Orthos Cm Cuniti 27arch 18diauplgpk10	219-0404	EUDAMEDFDA UDI	Class IIa	Active
L6r Bkt 22 Andrews T3 Pa Fcc -2/-30/6	138-0215	EUDAMED	Class IIa	Active
L1&2r Sws Db/Om 18 Roth Lo Ant 2/-1	338-0010	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 23	332-0323	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Pink Closed Space	639-0040	EUDAMEDFDA UDI	Class IIa	Active
5deg Sheath-L 036 W/Bhk Ea	088-4007	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 18, 2011	Z-0201-2012	—	terminated	Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
May 18, 2011	Z-0200-2012	—	terminated	Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Mar 15, 2011	Z-0639-2012	—	terminated	The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
Sep 9, 2010	Z-0160-2012	—	terminated	The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
Oct 2, 2009	Z-1148-2012	—	terminated	Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod, there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient's crown.
Feb 13, 2009	Z-1136-2012	—	terminated	The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9.
Aug 1, 2008	Z-1172-2012	—	terminated	A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error.
Oct 31, 2007	Z-0916-2008	—	terminated	Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
Nov 3, 2005	Z-0204-06	—	terminated	Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Nov 3, 2005	Z-0203-06	—	terminated	Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Nov 18, 2004	Z-0309-05	—	terminated	Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.