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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 4 of 134

Device	Model / Reference	Registries	Class	Status
Insignia	728-0113	FDA UDI	Class I	Active
Spark	728-3008	FDA UDI	Class II	Active
Ormco	204-1148	FDA UDI	Class I	Active
Inspire ICE	443-1411	FDA UDI	Class I	Unknown
Damon 3	491-4520	FDA UDI	Class II	Active
Damon 3	491-4050	FDA UDI	Class II	Active
Ormco	225-0003	FDA UDI	Class I	Active
Inspire ICE	444-1711	FDA UDI	Class I	Active
Legacy brkt	438-0131	FDA UDI	Class I	Active
Alexander SpiritMB	494-3725	FDA UDI	Class II	Unknown
Inspire ICE	443-1342	FDA UDI	Class I	Unknown
Inspire ICE	444-1343	FDA UDI	Class I	Active
Ormco Premium	866-2049	FDA UDI	Class I	Active
Ormco™ EtchFree Bonding	740-0520	FDA UDI	Class II	Active
Inspire ICE	444-3711	FDA UDI	Class II	Active
SpiritMB	740-1228	FDA UDI	Class II	Unknown
Tru-Arch Copper Ni-Ti	210-9235	FDA UDI	Class I	Active
Nexus Clear Roth	436-4711	FDA UDI	Class II	Unknown
Insignia	728-1409	FDA UDI	Class I	Active
System B	952-0001	FDA UDI	Class II	Active
Inspire ICE	443-1711	FDA UDI	Class I	Unknown
Damon 3	491-4521	FDA UDI	Class II	Active
Damon Q2	740-1538	FDA UDI	Class I	Active
Insignia	728-1123	FDA UDI	Class I	Active
Damon Q2	740-1536	FDA UDI	Class I	Active
Buchanan Plugger	952-0003	FDA UDI	Class II	Active
Ormco	422-0007	FDA UDI	Class I	Active
Inspire ICE	443-0510	FDA UDI	Class I	Unknown
Insignia	728-1204	FDA UDI	Class I	Active
Insignia	728-1406	FDA UDI	Class I	Active
Facebow	617-1003	FDA UDI	Class II	Active
Ormco	414-0003	FDA UDI	Class I	Active
Inspire ICE	443-0411	FDA UDI	Class I	Unknown
Satellite Cord	973-0303	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-1211	FDA UDI	Class II	Unknown
Ormco Premium	866-2048	FDA UDI	Class I	Active
Insignia	728-1102	FDA UDI	Class I	Active
Insignia	728-0408	FDA UDI	Class I	Active
SpiritMB	495-0410	FDA UDI	Class II	Unknown
Inspire ICE	443-0111	FDA UDI	Class I	Unknown
Insignia	728-0103	FDA UDI	Class I	Active
Ormco Premium	866-2024	FDA UDI	Class I	Active
SpiritMB	494-1420	FDA UDI	Class II	Unknown
Inspire ICE	444-0610	FDA UDI	Class I	Active
Legacy brkt	438-0177	FDA UDI	Class I	Active
Inspire ICE	746-4309	FDA UDI	Class II	Active
Inspire ICE	444-0140	FDA UDI	Class I	Unknown
System 1+	740-0107	FDA UDI	Class II	Unknown
Insignia	728-1118	FDA UDI	Class I	Active
Ormco	421-0102	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.