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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 5 of 134

Device	Model / Reference	Registries	Class	Status
Inspire ICE	746-4303	FDA UDI	Class I	Active
Inspire ICE	444-2211	FDA UDI	Class II	Active
Ormco	421-0106	FDA UDI	Class I	Active
Insignia	728-1305	FDA UDI	Class I	Active
Insignia	728-0118	FDA UDI	Class I	Active
Tubli-Seal EWT Xpress	33641	FDA UDI	Class II	Active
Ormco Premium	866-2036	FDA UDI	Class I	Active
SpiritMB	494-1301	FDA UDI	Class II	Unknown
Inspire ICE	443-1611	FDA UDI	Class I	Unknown
Inspire ICE	444-2111	FDA UDI	Class II	Active
Inspire ICE	444-1410	FDA UDI	Class I	Active
Touch N Heat	973-0212	FDA UDI	Class II	Active
Tevdek II	975-0050	FDA UDI	Class II	Active
Spark	728-3004	FDA UDI	Class II	Active
Inspire ICE	443-1340	FDA UDI	Class I	Unknown
Insignia	728-1302	FDA UDI	Class I	Active
Ormco	421-0107	FDA UDI	Class I	Active
Damon 3	491-5461	FDA UDI	Class II	Active
SpiritMB	740-1227	FDA UDI	Class II	Unknown
OptiBand	740-0194	FDA UDI	Class II	Active
Ormco	623-0251	FDA UDI	Class I	Active
SpiritMB	494-1411	FDA UDI	Class II	Unknown
Alexander SpiritMB	494-3310	FDA UDI	Class II	Unknown
Tru-Arch Copper Ni-Ti	205-6323	FDA UDI	Class I	Active
Inspire ICE	443-0611	FDA UDI	Class I	Unknown
SpiritMB	495-1615	FDA UDI	Class II	Unknown
Inspire ICE	443-1351	FDA UDI	Class I	Unknown
Damon 3	491-4051	FDA UDI	Class II	Active
SpiritMB	495-0615	FDA UDI	Class II	Unknown
Spark	728-3007	FDA UDI	Class II	Active
Vector Tas	601-0023	FDA UDI	Class II	Active
Insignia	728-1506	FDA UDI	Class I	Active
Damon Q2	740-1537	FDA UDI	Class I	Active
Ormco	422-0105	FDA UDI	Class I	Active
Sealapex Xpress	33639	FDA UDI	Class II	Active
Ormco	421-0007	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	210-9231	FDA UDI	Class I	Active
Ormco	242-0010	FDA UDI	Class I	Active
MiniEndo	973-0201	FDA UDI	Class II	Active
Insignia	728-1125	FDA UDI	Class I	Active
Ormco	628-1825	FDA UDI	Class I	Active
Xpress Sealer Mixing Tip	33680	FDA UDI	Class I	Active
Nexus Clear Roth	437-3611	FDA UDI	Class II	Unknown
System 1+	740-0101	FDA UDI	Class II	Unknown
Insignia	728-1402	FDA UDI	Class I	Active
SpiritMB	495-1301	FDA UDI	Class II	Unknown
Insignia	728-1404	FDA UDI	Class I	Active
Inspire ICE	443-2211	FDA UDI	Class II	Unknown
SpiritMB	495-0725	FDA UDI	Class II	Unknown
Inspire ICE	444-2110	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.