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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 7 of 134

Device	Model / Reference	Registries	Class	Status
Optiview	716-0050	FDA UDI	Class I	Active
Inspire ICE	443-1511	FDA UDI	Class I	Unknown
Insignia	728-1206	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6123	FDA UDI	Class I	Active
Inspire ICE	444-0343	FDA UDI	Class I	Active
Inspire ICE	444-3611	FDA UDI	Class II	Active
Ormco	625-2228	FDA UDI	Class I	Active
Tevdek II	975-0052	FDA UDI	Class II	Active
Facebow	212-3045	FDA UDI	Class II	Active
Inspire ICE	443-0241	FDA UDI	Class I	Unknown
Ormco	422-0002	FDA UDI	Class I	Active
SpiritMB	740-1223	FDA UDI	Class II	Active
Inspire ICE	746-4311	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	205-6133	FDA UDI	Class I	Active
SpiritMB	495-0025	FDA UDI	Class II	Unknown
Plugger	973-0220	FDA UDI	Class I	Active
Inspire ICE	746-4301	FDA UDI	Class I	Active
Insignia	728-1308	FDA UDI	Class I	Active
Nexus Clear Roth	436-3111	FDA UDI	Class II	Unknown
Ormco	801-0000	FDA UDI	Class I	Unknown
Nexus Clear Roth	437-4510	FDA UDI	Class II	Unknown
Insignia	728-1504	FDA UDI	Class I	Active
Nexus Clear Roth	436-4310	FDA UDI	Class II	Unknown
Insignia	728-1205	FDA UDI	Class I	Active
Inspire ICE	746-4400	FDA UDI	Class I	Active
Nexus Clear Roth	436-4511	FDA UDI	Class II	Unknown
Inspire ICE	746-4405	FDA UDI	Class I	Active
Basis	776-2103	FDA UDI	Class II	Active
Insignia	728-0511	FDA UDI	Class I	Active
Nexus Clear Roth	437-3610	FDA UDI	Class II	Unknown
Inspire ICE	444-0410	FDA UDI	Class I	Active
Inspire ICE	444-0010	FDA UDI	Class I	Unknown
Bright Tray	714-0053	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	210-9135	FDA UDI	Class I	Active
Damon Q2	740-1535	FDA UDI	Class I	Active
Tevdek II	975-0054	FDA UDI	Class II	Active
Ormco Premium	866-2040	FDA UDI	Class I	Active
Ormco	422-0008	FDA UDI	Class I	Active
Ormco	203-1115	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6433	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9221	FDA UDI	Class I	Active
SpiritMB	495-0301	FDA UDI	Class II	Unknown
Damon 3	491-4461	FDA UDI	Class II	Active
Inspire ICE	443-3510	FDA UDI	Class II	Unknown
Damon 3	491-4360	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	211-9235	FDA UDI	Class I	Active
Insignia	728-0102	FDA UDI	Class I	Active
Inspire ICE	746-4403	FDA UDI	Class I	Active
Inspire ICE	746-4411	FDA UDI	Class II	Active
Insignia	728-1407	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.