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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 13 of 134

Device	Model / Reference	Registries	Class	Status
Insignia	728-1111	FDA UDI	Class I	Active
SpiritMB	494-1410	FDA UDI	Class II	Unknown
Inspire ICE	443-1341	FDA UDI	Class I	Unknown
Tru-Arch Copper Ni-Ti	210-9132	FDA UDI	Class I	Active
Inspire ICE	443-0310	FDA UDI	Class I	Unknown
SpiritMB	494-1514	FDA UDI	Class II	Unknown
Nexus Clear Roth	437-3210	FDA UDI	Class II	Unknown
SpiritMB	495-1410	FDA UDI	Class II	Unknown
SpiritMB	495-0300	FDA UDI	Class II	Unknown
Ormco	422-0005	FDA UDI	Class I	Active
Ormco Premium	866-2020	FDA UDI	Class I	Active
Inspire ICE	746-4409	FDA UDI	Class II	Active
Ormco	421-0103	FDA UDI	Class I	Active
Inspire ICE	443-0143	FDA UDI	Class I	Unknown
Ormco	203-0006	FDA UDI	Class I	Active
Insignia	728-1203	FDA UDI	Class I	Active
Inspire ICE	444-0311	FDA UDI	Class I	Active
Insignia	728-0203	FDA UDI	Class I	Active
Inspire ICE	746-4306	FDA UDI	Class I	Active
Facebow	617-1012	FDA UDI	Class II	Active
Ormco Premium	866-2018	FDA UDI	Class I	Active
Vector Tas	601-0050	FDA UDI	Class II	Active
Insignia	728-1508	FDA UDI	Class I	Active
Ormco	204-1054	FDA UDI	Class I	Active
Insignia	728-0115	FDA UDI	Class I	Active
Ormco Premium	866-2026	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6332	FDA UDI	Class I	Active
SpiritMB	494-0320	FDA UDI	Class II	Unknown
Ormco	866-4013	FDA UDI	Class I	Active
Insignia	728-0116	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6223	FDA UDI	Class I	Active
Ormco	624-2228	FDA UDI	Class I	Active
Ormco	872-2001	FDA UDI	Class I	Active
Inspire ICE	443-0210	FDA UDI	Class I	Unknown
Inspire ICE	443-2110	FDA UDI	Class II	Active
Buchanan Plugger	952-0006	FDA UDI	Class II	Active
Inspire ICE	444-3311	FDA UDI	Class II	Active
Insignia	728-1115	FDA UDI	Class I	Active
Ormco	414-0102	FDA UDI	Class I	Active
SpiritMB	495-1411	FDA UDI	Class II	Unknown
Inspire ICE	443-0142	FDA UDI	Class I	Unknown
Damon 3	491-4111	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	210-9133	FDA UDI	Class I	Active
Damon Ultima	227-1123	FDA UDI	Class I	Active
Optiview	716-0051	FDA UDI	Class I	Active
Ormco Premium	866-2038	FDA UDI	Class I	Active
Ormco™ EtchFree Bonding	740-0525	FDA UDI	Class II	Active
SpiritMB	494-0321	FDA UDI	Class II	Unknown
Inspire ICE	444-3511	FDA UDI	Class II	Active
Ormco	421-0006	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.