Is this your brand? Sign in to claim ownership.

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 2 of 134

Device	Model / Reference	Registries	Class	Status
Tru-Arch Copper Ni-Ti	205-6422	FDA UDI	Class I	Active
Sealapex	18598	FDA UDI	Class II	Active
Insignia	728-1117	FDA UDI	Class I	Active
Inspire ICE	444-0710	FDA UDI	Class I	Active
Sentry Headgear	715-0001	FDA UDI	Class II	Active
Insignia	728-0405	FDA UDI	Class I	Active
Inspire ICE	443-0711	FDA UDI	Class I	Unknown
Inspire ICE	746-4304	FDA UDI	Class I	Active
Insignia	728-1403	FDA UDI	Class I	Active
Enlight LV	740-0299	FDA UDI	Class II	Active
Inspire ICE	746-4407	FDA UDI	Class I	Active
SpiritMB	494-0221	FDA UDI	Class II	Unknown
Ormco	422-0006	FDA UDI	Class I	Active
Spirit	740-0077	FDA UDI	Class II	Active
Insignia	728-0400	FDA UDI	Class I	Active
Insignia	728-0404	FDA UDI	Class I	Active
Inspire ICE	443-0342	FDA UDI	Class I	Unknown
Inspire ICE	444-1511	FDA UDI	Class I	Active
Damon Q2	740-1534	FDA UDI	Class I	Active
Legacy brkt	136-1606	FDA UDI	Class I	Active
Inspire ICE	444-0240	FDA UDI	Class I	Active
Legacy brkt	438-0120	FDA UDI	Class I	Active
Inspire ICE	444-0711	FDA UDI	Class I	Active
Insignia	728-0407	FDA UDI	Class I	Active
Tevdek II	975-0065	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	205-6221	FDA UDI	Class I	Active
Insignia	728-1500	FDA UDI	Class I	Active
Inspire ICE	443-0242	FDA UDI	Class I	Unknown
Insignia	728-1103	FDA UDI	Class I	Active
Inspire ICE	444-0411	FDA UDI	Class I	Active
SpiritMB	495-0121	FDA UDI	Class II	Unknown
Vector Tas	601-0021	FDA UDI	Class II	Active
Insignia	728-1116	FDA UDI	Class I	Active
Lip Clip	973-0227	FDA UDI	Class II	Active
Ormco	414-0104	FDA UDI	Class I	Active
Insignia	728-0501	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9123	FDA UDI	Class I	Active
Insignia	728-1107	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9222	FDA UDI	Class I	Active
Insignia	728-0302	FDA UDI	Class I	Active
Inspire ICE	444-0511	FDA UDI	Class I	Active
Inspire ICE	444-1610	FDA UDI	Class I	Active
Legacy brkt	438-0116	FDA UDI	Class I	Active
SpiritMB	494-1300	FDA UDI	Class II	Unknown
Insignia	728-0207	FDA UDI	Class I	Active
Inspire ICE	444-0210	FDA UDI	Class I	Active
Alexander SpiritMB	494-3342	FDA UDI	Class II	Unknown
Insignia	728-0410	FDA UDI	Class I	Active
Damon 3	491-5331	FDA UDI	Class II	Active
Ormco Premium	866-2027	FDA UDI	Class I	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.