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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 14 of 134

Device	Model / Reference	Registries	Class	Status
Bright Tray	714-0052	FDA UDI	Class I	Active
Simple Probe Tip	973-0228	FDA UDI	Class II	Active
Damon 3	491-4460	FDA UDI	Class II	Active
Straight-Wire Synthesis	339-1520	FDA UDI	Class I	Active
File Clip	973-0310	FDA UDI	Class II	Unknown
Tru-Arch Copper Ni-Ti	205-6222	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	211-9131	FDA UDI	Class I	Active
Insignia	728-0509	FDA UDI	Class I	Active
Ormco Premium	866-2019	FDA UDI	Class I	Active
Inspire ICE	444-1340	FDA UDI	Class I	Active
Insignia	728-1201	FDA UDI	Class I	Active
Ormco	422-0106	FDA UDI	Class I	Active
Ormco	672-3000	FDA UDI	Class I	Active
Inspire ICE	444-1310	FDA UDI	Class I	Active
Ormco	414-0001	FDA UDI	Class I	Active
Insignia	728-0305	FDA UDI	Class I	Active
Damon 3	491-4020	FDA UDI	Class II	Active
Basis	776-2104	FDA UDI	Class II	Active
Insignia	728-0126	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6322	FDA UDI	Class I	Active
Plugger	973-0221	FDA UDI	Class I	Active
Alexander SpiritMB	494-0110	FDA UDI	Class II	Unknown
Tru-Arch Copper Ni-Ti	210-9221	FDA UDI	Class I	Active
#n/A	070-0776	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	205-6423	FDA UDI	Class I	Active
Lip Hooks	973-0313	FDA UDI	Class II	Unknown
Vitality Scanner	973-0234	FDA UDI	Class II	Unknown
Ormco Premium	866-2056	FDA UDI	Class I	Active
Bright Tray	714-0041	FDA UDI	Class I	Active
Legacy brkt	438-0119	FDA UDI	Class I	Active
Elements	973-0304	FDA UDI	Class II	Unknown
Ormco Premium	866-2017	FDA UDI	Class I	Active
Elements	973-0300	FDA UDI	Class II	Active
Heat Carrier	973-0215	FDA UDI	Class II	Active
Long Probe Tip	973-0233	FDA UDI	Class II	Unknown
Optiview	716-0052	FDA UDI	Class I	Active
Bright Tray	714-0042	FDA UDI	Class I	Active
Ormco Premium	866-2043	FDA UDI	Class I	Active
Ormco Premium	866-2030	FDA UDI	Class I	Active
Ormco Premium	866-2034	FDA UDI	Class I	Active
Legacy brkt	438-0185	FDA UDI	Class I	Active
Tru-Arch Copper Ni-Ti	210-9123	FDA UDI	Class I	Active
Spoon Tip	973-0218	FDA UDI	Class II	Active
Basis	776-2101	FDA UDI	Class II	Active
Pulp Canal Sealer	24875	FDA UDI	Class II	Active
Tru-Arch Copper Ni-Ti	210-9234	FDA UDI	Class I	Active
Peerless Sgl 5deg Lfm-27trqx022 Lr	342-2216	EUDAMEDFDA UDI	Class IIa	Active
U3r Damon Q .022 +11/+5/0 Super Tq	491-6484	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE CUNITI .018 x .018 MED PK10	204-2142	EUDAMEDFDA UDI	Class IIa	Active
REVERSE CURVE NiTi DAMON 019 X 025 PK5	216-3809	EUDAMEDFDA UDI	Class IIa	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.