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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 8 of 134

Device	Model / Reference	Registries	Class	Status
Inspire ICE	444-0142	FDA UDI	Class I	Unknown
Inspire ICE	444-0510	FDA UDI	Class I	Active
Insignia	728-0506	FDA UDI	Class I	Active
Inspire ICE	443-3410	FDA UDI	Class II	Unknown
Tevdek II	975-0063	FDA UDI	Class II	Active
Ormco Premium	866-2022	FDA UDI	Class I	Active
Insignia	728-0308	FDA UDI	Class I	Active
Insignia	728-1400	FDA UDI	Class I	Active
Inspire ICE	443-1410	FDA UDI	Class I	Unknown
Inspire ICE	444-0611	FDA UDI	Class I	Active
Inspire ICE	746-4406	FDA UDI	Class I	Active
Nexus Clear Roth	437-3211	FDA UDI	Class II	Unknown
Damon 3	491-4330	FDA UDI	Class II	Active
Inspire ICE	443-0141	FDA UDI	Class I	Unknown
Tru-Arch Copper Ni-Ti	210-9223	FDA UDI	Class I	Active
Ormco Premium	866-2023	FDA UDI	Class I	Active
Vector Tas	601-0051	FDA UDI	Class II	Active
SpiritMB	494-0220	FDA UDI	Class II	Unknown
Tru-Arch Align	227-3398	FDA UDI	Class I	Active
Ormco Premium	866-2050	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6122	FDA UDI	Class I	Active
Insignia	728-0106	FDA UDI	Class I	Active
SpiritMB	495-0110	FDA UDI	Class II	Unknown
Insignia	728-0204	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6432	FDA UDI	Class I	Active
Pulp Canal Sealer	24873	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	210-9131	FDA UDI	Class I	Active
Nexus Clear Roth	436-4510	FDA UDI	Class II	Unknown
SpiritMB	495-0211	FDA UDI	Class II	Unknown
Inspire ICE	444-0342	FDA UDI	Class I	Active
Damon 3	491-4121	FDA UDI	Class II	Active
Nexus Clear Roth	436-4311	FDA UDI	Class II	Unknown
Ormco	204-1042	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	210-9222	FDA UDI	Class I	Active
Inspire ICE	444-1611	FDA UDI	Class I	Active
SpiritMB	495-1514	FDA UDI	Class II	Unknown
SpiritMB	495-0230	FDA UDI	Class II	Unknown
Inspire ICE	444-0011	FDA UDI	Class I	Unknown
Inspire ICE	443-1311	FDA UDI	Class I	Unknown
SpiritMB	494-1421	FDA UDI	Class II	Unknown
Insignia	728-0117	FDA UDI	Class I	Active
Tru-Arch Align	227-3402	FDA UDI	Class I	Active
Ormco	204-1048	FDA UDI	Class I	Active
Ormco	211-0443	FDA UDI	Class I	Active
Inspire ICE	444-0242	FDA UDI	Class I	Active
Tevdek II	975-0056	FDA UDI	Class II	Active
Legacy brkt	438-0184	FDA UDI	Class I	Active
Damon 3	491-5361	FDA UDI	Class II	Active
Insignia	203-1119	FDA UDI	Class I	Active
SpiritMB	495-1300	FDA UDI	Class II	Unknown

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.