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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 9 of 134

Device	Model / Reference	Registries	Class	Status
Sentry Headgear	715-0002	FDA UDI	Class II	Active
Inspire ICE	444-1341	FDA UDI	Class I	Active
Ormco	422-0108	FDA UDI	Class I	Active
Inspire ICE	444-0141	FDA UDI	Class I	Unknown
Damon 3	491-4361	FDA UDI	Class II	Active
Inspire ICE	444-1350	FDA UDI	Class I	Active
Insignia	728-0205	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	210-9121	FDA UDI	Class I	Active
Ormco	414-0005	FDA UDI	Class I	Active
Damon 3	491-4110	FDA UDI	Class II	Active
Vitality Probe	973-0308	FDA UDI	Class II	Unknown
Bright Tray	714-0044	FDA UDI	Class I	Active
Ormco Premium	866-2033	FDA UDI	Class I	Active
Inspire ICE	443-0343	FDA UDI	Class I	Unknown
Tru-Arch Copper Ni-Ti	211-9122	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9232	FDA UDI	Class I	Active
Inspire ICE	746-4401	FDA UDI	Class I	Active
Insignia	728-1106	FDA UDI	Class I	Active
Ormco	422-0004	FDA UDI	Class I	Active
OptiBand	740-0193	FDA UDI	Class II	Active
Damon 3	491-4220	FDA UDI	Class II	Active
MiniEndo II	973-0236	FDA UDI	Class II	Active
Insignia	728-0201	FDA UDI	Class I	Active
Ormco Premium	866-2029	FDA UDI	Class I	Active
Insignia	728-1408	FDA UDI	Class I	Active
Ormco	414-0106	FDA UDI	Class I	Active
Insignia	728-1100	FDA UDI	Class I	Active
Damon 3	491-5621	FDA UDI	Class II	Active
Insignia	728-0200	FDA UDI	Class I	Active
Ormco	203-1117	FDA UDI	Class I	Active
System 1+	740-0104	FDA UDI	Class II	Unknown
Damon 3	491-4430	FDA UDI	Class II	Active
Tevdek II	975-0067	FDA UDI	Class II	Active
Buchanan Plugger	952-0004	FDA UDI	Class II	Active
Insignia	728-0500	FDA UDI	Class I	Active
Bright Tray	714-0043	FDA UDI	Class I	Active
Ormco	088-4052	FDA UDI	Class I	Active
Inspire ICE	444-0310	FDA UDI	Class I	Active
Ormco	211-0442	FDA UDI	Class I	Active
Damon 3	491-4120	FDA UDI	Class II	Active
Damon 3	491-4620	FDA UDI	Class II	Active
Bifurcated Probe	973-0307	FDA UDI	Class II	Unknown
Inspire ICE	443-2111	FDA UDI	Class II	Unknown
Spirit MB	740-1221	FDA UDI	Class II	Active
Inspire ICE	443-1510	FDA UDI	Class I	Unknown
Insignia	728-0111	FDA UDI	Class I	Active
Ormco Premium	866-2014	FDA UDI	Class I	Active
Insignia	728-0307	FDA UDI	Class I	Active
Inspire ICE	746-4404	FDA UDI	Class I	Active
Ormco Premium	866-2037	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.