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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 10 of 134

Device	Model / Reference	Registries	Class	Status
Inspire ICE	444-0211	FDA UDI	Class I	Active
Contact Clip	951-0008	FDA UDI	Class II	Active
Ormco	414-0101	FDA UDI	Class I	Active
Ormco	422-0104	FDA UDI	Class I	Active
Facebow	617-1011	FDA UDI	Class II	Active
Inspire ICE	443-0511	FDA UDI	Class I	Unknown
Elements	973-0311	FDA UDI	Class II	Unknown
Inspire ICE	443-0243	FDA UDI	Class I	Unknown
Insignia	728-0127	FDA UDI	Class I	Active
Symetri Clear	717-0021	FDA UDI	Class II	Active
Insignia	728-0100	FDA UDI	Class I	Active
Ormco	422-0003	FDA UDI	Class I	Active
Inspire ICE	746-4302	FDA UDI	Class I	Active
Insignia	728-0409	FDA UDI	Class I	Active
Inspire ICE	746-4307	FDA UDI	Class I	Active
Insignia	728-0112	FDA UDI	Class I	Active
Insignia	728-0105	FDA UDI	Class I	Active
Inspire ICE	443-0410	FDA UDI	Class I	Unknown
Insignia	728-1510	FDA UDI	Class I	Active
Inspire ICE	444-0143	FDA UDI	Class I	Active
Inspire ICE	444-1351	FDA UDI	Class I	Active
SpiritMB	494-0121	FDA UDI	Class II	Unknown
SpiritMB	494-0210	FDA UDI	Class II	Unknown
Ormco	204-1154	FDA UDI	Class I	Active
Inspire ICE	443-3411	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-3514	FDA UDI	Class II	Unknown
Damon Q2	740-1531	FDA UDI	Class I	Active
Inspire ICE	443-0211	FDA UDI	Class I	Unknown
Enlight XM	740-0296	FDA UDI	Class II	Active
Inspire ICE	444-3510	FDA UDI	Class II	Active
Facebow	617-1001	FDA UDI	Class II	Active
Ormco	088-4051	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9231	FDA UDI	Class I	Active
Tru-Arch Align	227-3400	FDA UDI	Class I	Active
Porcelain Primer	740-0012	FDA UDI	Class II	Active
Ormco	414-0103	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6132	FDA UDI	Class I	Active
Inspire ICE	444-3610	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	211-9133	FDA UDI	Class I	Active
Ormco	421-0004	FDA UDI	Class I	Active
Damon 3	491-4021	FDA UDI	Class II	Active
Inspire ICE	443-0351	FDA UDI	Class I	Unknown
Vector Tas	601-0020	FDA UDI	Class II	Active
Inspire ICE	443-0350	FDA UDI	Class I	Unknown
Hot Pulp Test Tip	973-0219	FDA UDI	Class II	Active
Insignia	728-0406	FDA UDI	Class I	Active
Nexus Clear Roth	437-4310	FDA UDI	Class II	Unknown
Inspire ICE	443-1350	FDA UDI	Class I	Unknown
Inspire ICE	444-2210	FDA UDI	Class II	Active
Vector Tas	601-0003	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.