Is this your brand? Sign in to claim ownership.

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 126 of 134

Device	Model / Reference	Registries	Class	Status
Upper Right First Molar Washbon Band Size 10	377-0010	EUDAMEDFDA UDI	Class IIa	Active
U1l Sws Db/Om 18 Andrews Central 5/7	338-0121	EUDAMEDFDA UDI	Class IIa	Active
Damon Purple Tma - Low Fric 019x025 Pk5	227-1143	EUDAMEDFDA UDI	Class IIa	Active
Damon Ss Posted 26mm 16x25 Nd Bulk10pk	227-1028	EUDAMEDFDA UDI	Class IIa	Active
Spark Junior (phase 1) - Single Arch	728-3220-A	EUDAMED	Class IIa	Active
Facebow S/R Long Sz 4 .044 Dia.	200-0204	EUDAMEDFDA UDI	Class IIa	Active
U3r Twin Db/Mm 18 Roth Sr Dbhk 13/-2/4	363-1012	EUDAMED	Class IIa	Active
L6r Llbt Bkt 2245 Andrews Hk Fcc 2/-30	138-0259	EUDAMEDFDA UDI	Class IIa	Active
L4r Twin Bkt 18 Roth Dbhk -1/-17/4	163-1058	EUDAMEDFDA UDI	Class IIa	Active
Mini Three Jaw Pliers	803-0412	EUDAMEDFDA UDI	Class I	Active
Orthos Bios Ll2bi-17tg-Offset Hk .018	348-7917	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Wdx-20tx022	512-2103	EUDAMEDFDA UDI	Class IIa	Active
Diamond Mtw Llcus 1700452 -11t+6a18hk	347-1308	EUDAMED	Class IIa	Active
U2l Minitwin Vs Db/Mtwin 18 Roth 9/8	318-0211	EUDAMED	Class IIa	Active
Orth Accent Lsm 5sgl -10x.022 Lt Wdx	342-4213	EUDAMEDFDA UDI	Class IIa	Active
U7r Bkt 22 Andrews Mt Hk 0/-9/10	138-0167	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 17	332-0317	EUDAMEDFDA UDI	Class IIa	Active
Diamond Wtw Urcus 1700524 -7t +10a018	347-1003	EUDAMED	Class IIa	Active
Facebow S/R Super Short Szsm .044 Dia	200-0267	EUDAMEDFDA UDI	Class IIa	Active
Sheath .036 No Hook With Window - 25 Pack	704-4013	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamnd Tw Lrcus 1510442-11t+6a22	351-0442	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn/Hk Ur Bic -7t 0a 18	303-1510	EUDAMED	Class IIa	Active
Orthos C/M-Ul 2nd Bi -8t4a018	454-0513	EUDAMEDFDA UDI	Class IIa	Active
L4l Attract Db/Am 18 Andrews 2/-17	363-7033	EUDAMED	Class IIa	Active
Mini-V Diam Ur Cusp W/Hk 0t +10a 022	351-7330	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamond Ulcus W/Hk -7t +10a 022	351-1321	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 LM 020X020 NiTi DIMPLE 10PK	227-3675	EUDAMEDFDA UDI	Class IIa	Active
Orthoscm Sst Arch .020 Dia Upsm Pk10	219-1572	EUDAMEDFDA UDI	Class IIa	Active
L3l Twin Db/Mm 18 Roth/T1 Dbhk 7/-11/2	363-1063	EUDAMED	Class IIa	Active
Lingual Terminal Tube Band 10x022 Ul	136-1616	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 18	371-0018	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Pad Molar U/L	300-0038	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 21	460-0021	EUDAMEDFDA UDI	Class IIa	Active
Spark Junior (phase 2) - Dual Arch	728-3230-D	EUDAMED	Class IIa	Active
U3l Minitwin Db/Mtwin 18 Andrews 11/-7	328-0321	EUDAMEDFDA UDI	Class IIa	Active
U2r Damon Clear .022 -5/+9/0 Lo Tq	497-6472	EUDAMEDFDA UDI	Class IIa	Active
Pref Ling Arch 35 Cuniti Up 017x017 Sz3 Pk10	205-0074	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 2245 And T2 Hk Cp 2/-14/14	138-0045	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band With Lug Size 16	331-0316	EUDAMEDFDA UDI	Class IIa	Active
L1r Damon Q2 022 -11/+2/0 Low Tq	491-8814	EUDAMEDFDA UDI	Class IIa	Active
Arch Tma Rect Max .021 X .025 Pk 10	202-0013	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Std High Retention Band Size 14	651-0114	EUDAMEDFDA UDI	Class IIa	Active
L7r Accent Mini Mbt .018 -10/0/+5	340-1376	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 17x25lolgpk10	219-4310	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultima Band Size 22	459-0022	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 26	372-0026	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 24	488-0024	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 6	374-0006	EUDAMEDFDA UDI	Class IIa	Active
U4&5 Univ Symetri Clear Mclaughlin, Bennett & Trevisi .022 -7/0/0	419-1510	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 9	378-0009	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.