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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 119 of 134

Device	Model / Reference	Registries	Class	Status
Universal Upper Bicuspid Band Size 16	331-0116	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Wdx 0tx18 Ul/Lr	515-0202	EUDAMEDFDA UDI	Class IIa	Active
Wire 7in.0190 Dead Soft Respond Pk10	264-1190	EUDAMED	Class IIa	Active
L1r Damon Q .022 -11/+2/0 Lo Tq	491-6414	EUDAMEDFDA UDI	Class IIa	Active
L1&2r Twin Db/Mm 18 Andrews Spec 0/-1	363-1079	EUDAMED	Class IIa	Active
L6l Bkt 18 Andrews Mt Hk 2/-30	137-0122	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 24	377-0024	EUDAMEDFDA UDI	Class IIa	Active
Respond Wire .0210 Diax14in Lgth Pk10	264-1121	EUDAMED	Class IIa	Active
Tru-Arch Ss Posted 26mm Lm 019x025 Nd Bulk 10pk	227-7013	EUDAMEDFDA UDI	Class IIa	Active
U2l Sws Db/Om 22 Super Torque Lateral 9/10	339-0241	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 29	435-0029	EUDAMEDFDA UDI	Class IIa	Active
L4r Damon Q .022 -5/+4/0 Hi Tq Hk	491-7642	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 24	652-0124	EUDAMEDFDA UDI	Class IIa	Active
U3l Mtwin Sr Vs Db/Mtwin 18 Roth 13/-2/4	318-0311	EUDAMED	Class IIa	Active
Orthoscm Sst Arch .020 Dia Losm Pk10	219-1562	EUDAMEDFDA UDI	Class IIa	Active
L3r Twin Db/Mm 18 Roth/T1 7/-11/2	363-1069	EUDAMED	Class IIa	Active
U6r Obt Db/Ul 2245 Andrews Mt Hk 5/-9/10	438-0059	EUDAMED	Class IIa	Active
L5r Damon Q G-Off .022 -17/+4/0 Std Tq	491-6550	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 16	654-0116	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Turbo Arch 17x25 Upsm Pk10	219-6210	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultimax Band Size 14	457-0114	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP27D 019x025LS PK10	211-9105	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 10	376-0010	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 9	372-0009	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 11	332-0311	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE SST .018 x .018 MED PK10	204-2302	EUDAMEDFDA UDI	Class IIa	Active
Mini Mesh Goff Ll 2bic Hk -22t 0a 022	351-1753	EUDAMEDFDA UDI	Class IIa	Active
L6l Db/Ul 22 Andrews Mt Hk 2/-30	438-0103	EUDAMEDFDA UDI	Class IIa	Active
L7r Db/Ul 18 Roth Mt Hk -1/-30/4	437-0020	EUDAMEDFDA UDI	Class IIa	Active
L5l Twin Db/Ul 22 Andrews T1 Pa 0/-22/2	464-1035	EUDAMED	Class IIa	Active
U6l Cbt Db/Ul 2245 And T4 Hkcap 0/-9/0	438-0146	EUDAMED	Class IIa	Active
TRU-ARCH ALIGN SE200 UM 019X025 Niti DIMPLE 10PK	227-3143	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 15	488-0015	EUDAMEDFDA UDI	Class IIa	Active
Ad Prot. Facemask Blue - International	716-1050	EUDAMEDFDA UDI	Class I	Active
Lower Left Second Molar Std High Retention Band Size 8	654-0008	EUDAMEDFDA UDI	Class IIa	Active
Master Pouch 15 3g 1/4 Lt Leopard	635-0059	EUDAMEDFDA UDI	Class IIa	Active
L6l Bkt 22 Andrews T3 Pa Fcc -2/-30/6	137-0215	EUDAMED	Class IIa	Active
Mini-Diamond Tw Ulcen 1510121+7t+5a22	351-0121	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band Size 21	331-0121	EUDAMEDFDA UDI	Class IIa	Active
U4r Ti-Orthos G-Off W/Hk .018 -6/0/0	448-6412	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Ntwin Lant 1120007 -1t 0a 022	342-1500	EUDAMEDFDA UDI	Class IIa	Active
Mini Mesh Goff Lwr 2bic -22t 0a 022	351-0755	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 28	457-0028	EUDAMEDFDA UDI	Class IIa	Active
Diamond Mtw Lrcus 1700546 +7t +5a 018	347-2223	EUDAMED	Class IIa	Active
L4l Minitwin Rec Db/Ul 22 Andrews Bhk 0/-17	429-1621	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Attract Db/Am 18 Andrews Bhk 2/-7	363-7060	EUDAMED	Class IIa	Active
U1l Damon Ultima 22 Retrocline Tq	333-2110	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Lrcus 1500432 Whk -7t+6a18	350-1432	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Lr Wdx-32tx018	513-2108	EUDAMEDFDA UDI	Class IIa	Active
L6l Dbt Bkt 22 Roth Mt Hk Bal -1/-30/4	137-0251	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

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Notified Bodies

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Authorities

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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.