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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 11 of 134

Device	Model / Reference	Registries	Class	Status
Nexus Clear Roth	437-3111	FDA UDI	Class II	Unknown
Nexus Clear Roth	437-3110	FDA UDI	Class II	Unknown
Insignia	728-1303	FDA UDI	Class I	Active
Insignia	728-1502	FDA UDI	Class I	Active
Nexus Clear Roth	436-4710	FDA UDI	Class II	Unknown
Insignia	728-1207	FDA UDI	Class I	Active
SpiritMB	494-1615	FDA UDI	Class II	Unknown
Short Probe Tip	973-0232	FDA UDI	Class II	Unknown
Damon 3	491-5721	FDA UDI	Class II	Active
Facebow	617-1015	FDA UDI	Class II	Active
Damon 3	491-5460	FDA UDI	Class II	Active
Inspire ICE	443-1710	FDA UDI	Class I	Unknown
Ormco Premium	866-2031	FDA UDI	Class I	Active
Damon 3	491-5430	FDA UDI	Class II	Active
Buchanan Plugger	952-0031	FDA UDI	Class II	Active
Heat Carrier	973-0214	FDA UDI	Class II	Active
Inspire ICE	443-0140	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6121	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9121	FDA UDI	Class I	Active
Ormco Premium	866-2021	FDA UDI	Class I	Active
SpiritMB	495-1725	FDA UDI	Class II	Unknown
System B Handpiece	952-0008	FDA UDI	Class I	Active
Damon 3	491-4211	FDA UDI	Class II	Active
Damon 3	491-4720	FDA UDI	Class II	Active
SpiritMB	495-0514	FDA UDI	Class II	Unknown
Ormco Premium	866-2013	FDA UDI	Class I	Active
Inspire ICE	746-4410	FDA UDI	Class II	Active
Inspire ICE	444-0241	FDA UDI	Class I	Active
Sealapex	18432	FDA UDI	Class II	Active
Insignia	728-0502	FDA UDI	Class I	Active
Inspire ICE	444-0110	FDA UDI	Class I	Unknown
Inspire ICE	444-0111	FDA UDI	Class I	Unknown
Misc	740-0042	FDA UDI	Class I	Active
Insignia	728-0303	FDA UDI	Class I	Active
Ormco	421-0105	FDA UDI	Class I	Active
Damon 3	491-5720	FDA UDI	Class II	Active
SpiritMB	494-0120	FDA UDI	Class II	Unknown
SpiritMB	495-0111	FDA UDI	Class II	Unknown
Inspire ICE	444-0243	FDA UDI	Class I	Active
SpiritMB	740-1222	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	211-9234	FDA UDI	Class I	Active
SpiritMB	740-1221	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-3063	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-3062	FDA UDI	Class II	Unknown
Inspire ICE	443-3611	FDA UDI	Class II	Unknown
Ormco™ EtchFree Bonding	740-0500	FDA UDI	Class II	Active
Inspire ICE	443-3710	FDA UDI	Class II	Unknown
SpiritMB	494-1725	FDA UDI	Class II	Unknown
Insignia	728-1503	FDA UDI	Class I	Active
Enlight LV	740-0278	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.