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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 3 of 134

Device	Model / Reference	Registries	Class	Status
Insignia	728-1112	FDA UDI	Class I	Active
Basis	776-2102	FDA UDI	Class II	Active
Ormco Premium	866-2042	FDA UDI	Class I	Active
Vector Tas	601-0010	FDA UDI	Class II	Active
Damon 3	491-4240	FDA UDI	Class II	Active
Insignia	728-0107	FDA UDI	Class I	Active
Insignia	728-0101	FDA UDI	Class I	Active
Damon 3	491-5521	FDA UDI	Class II	Active
Tubli-Seal	00340	FDA UDI	Class II	Active
Damon 3	491-5431	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	211-9132	FDA UDI	Class I	Active
SpiritMB	495-0210	FDA UDI	Class II	Unknown
Ormco	421-0001	FDA UDI	Class I	Active
Spark	728-3009	FDA UDI	Class II	Active
Insignia	728-0504	FDA UDI	Class I	Active
Ormco Premium	866-2046	FDA UDI	Class I	Active
SpiritMB	495-0120	FDA UDI	Class II	Unknown
SpiritMB	740-1226	FDA UDI	Class II	Active
Buchanan Plugger	952-0005	FDA UDI	Class II	Active
Inspire ICE	443-0610	FDA UDI	Class I	Unknown
Inspire ICE	443-1343	FDA UDI	Class I	Unknown
Ormco Premium	866-2044	FDA UDI	Class I	Active
Ormco	801-0039	FDA UDI	Class I	Active
Crown Test Tip	973-0309	FDA UDI	Class II	Unknown
SpiritMB	495-0411	FDA UDI	Class II	Unknown
Insignia	728-0505	FDA UDI	Class I	Active
Damon 3	491-4210	FDA UDI	Class II	Active
Insignia	728-0202	FDA UDI	Class I	Active
Ormco	422-0103	FDA UDI	Class I	Active
Damon 3	491-5360	FDA UDI	Class II	Active
Nexus Clear Roth	436-3611	FDA UDI	Class II	Unknown
Ormco	421-0104	FDA UDI	Class I	Active
Elements	973-0301	FDA UDI	Class II	Active
SpiritMB	494-1321	FDA UDI	Class II	Unknown
Inspire ICE	444-1411	FDA UDI	Class I	Active
Inspire ICE	746-4305	FDA UDI	Class I	Active
Insignia	728-1113	FDA UDI	Class I	Active
Insignia	728-1509	FDA UDI	Class I	Active
Insignia	728-0306	FDA UDI	Class I	Active
Alexander SpiritMB	494-3055	FDA UDI	Class II	Unknown
Insignia	728-1105	FDA UDI	Class I	Active
Inspire ICE	444-0351	FDA UDI	Class I	Active
Alexander SpiritMB	494-1210	FDA UDI	Class II	Unknown
Ormco	414-0004	FDA UDI	Class I	Active
Nexus Clear Roth	437-4311	FDA UDI	Class II	Unknown
Insignia	728-1101	FDA UDI	Class I	Active
Insignia	728-0301	FDA UDI	Class I	Active
SpiritMB	494-0025	FDA UDI	Class II	Unknown
Damon 3	491-4331	FDA UDI	Class II	Active
SpiritMB	494-0514	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.