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 6 of 134

Device	Model / Reference	Registries	Class	Status
Tru-Arch Copper Ni-Ti	205-6321	FDA UDI	Class I	Active
SpiritMB	494-1320	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-0111	FDA UDI	Class II	Unknown
Ormco Premium	866-2041	FDA UDI	Class I	Active
SpiritMB	494-0615	FDA UDI	Class II	Unknown
Inspire ICE	443-0110	FDA UDI	Class I	Active
Inspire ICE	444-1710	FDA UDI	Class I	Active
Damon Q2	740-1532	FDA UDI	Class I	Active
Insignia	728-0508	FDA UDI	Class I	Active
Inspire ICE	444-3310	FDA UDI	Class II	Active
Ormco	225-0002	FDA UDI	Class I	Active
Legacy brkt	438-0126	FDA UDI	Class I	Active
Damon 3	491-4431	FDA UDI	Class II	Active
Nexus Clear Roth	436-3110	FDA UDI	Class II	Unknown
SpiritMB	494-0420	FDA UDI	Class II	Unknown
Insignia	728-1301	FDA UDI	Class I	Active
Ormco	421-0002	FDA UDI	Class I	Active
Alexander SpiritMB	494-3311	FDA UDI	Class II	Unknown
Facebow	617-1013	FDA UDI	Class II	Active
Inspire ICE	443-0011	FDA UDI	Class I	Unknown
Inspire ICE	443-0311	FDA UDI	Class I	Unknown
Insignia	728-1126	FDA UDI	Class I	Active
Inspire ICE	746-4402	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9135	FDA UDI	Class I	Active
Nexus Clear Roth	436-3211	FDA UDI	Class II	Unknown
Vector Tas	601-0022	FDA UDI	Class II	Active
Damon 3	491-4621	FDA UDI	Class II	Active
Tubli-Seal EWT	25903	FDA UDI	Class II	Active
Damon 3	491-5520	FDA UDI	Class II	Active
Ormco	414-0002	FDA UDI	Class I	Active
Facebow	617-1004	FDA UDI	Class II	Active
Inspire ICE	444-0350	FDA UDI	Class I	Active
Nexus Clear Roth	436-3610	FDA UDI	Class II	Unknown
Ormco	204-1142	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6233	FDA UDI	Class I	Active
SpiritMB	495-0231	FDA UDI	Class II	Unknown
Ormco	421-0005	FDA UDI	Class I	Active
Inspire ICE	444-1342	FDA UDI	Class I	Active
Pulp Canal Sealer	24874	FDA UDI	Class II	Active
Ormco	421-0108	FDA UDI	Class I	Active
SimpliSeal	972-0082	FDA UDI	Class II	Active
Damon Q2	740-1533	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9233	FDA UDI	Class I	Active
Insignia	728-1501	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6333	FDA UDI	Class I	Active
Insignia	728-1505	FDA UDI	Class I	Active
Ormco Premium	866-2045	FDA UDI	Class I	Active
Ormco	211-0452	FDA UDI	Class I	Active
SpiritMB	494-0410	FDA UDI	Class II	Unknown
Inspire ICE	444-3410	FDA UDI	Class II	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.