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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 20 of 134

Device	Model / Reference	Registries	Class	Status
Twn Bkt Wedge Med Lwr 1stbic-17trq018	170-0122	EUDAMEDFDA UDI	Class IIa	Active
Ni-Ti Broad Arch Upsml 0180 0250 Pk10	210-0504	EUDAMEDFDA UDI	Class IIa	Active
L7l Db/Ul 18 Roth Mt Hk -1/-30/4	437-0120	EUDAMEDFDA UDI	Class IIa	Active
U3r Minitwin Db/Mtwin 18 Andrews 11/-7	328-0320	EUDAMEDFDA UDI	Class IIa	Active
U1r Minitwin Db/Mtwin 22 Suptq 5/17	329-0140	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Tma 016 X 022 Upsm Pk10	219-2208	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -20t 022 Ndx Ll	342-6317	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Posted 36mm Um 016x022 Nd Bulk 10pk	227-7035	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Damon Clear -11/+2/0 Std	497-6490	EUDAMEDFDA UDI	Class IIa	Active
Assy Orthos Cm Sgl 15ufm -10x18 Ur	190-0318	EUDAMEDFDA UDI	Class IIa	Active
U3r Twin Db/Mm 22 Andrews T1 Pa 13/-7/2	364-1019	EUDAMED	Class IIa	Active
Upper Right Second Molar Washbon Band Size 10	371-0010	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP35D 017x025UL PK10	210-9214	EUDAMEDFDA UDI	Class IIa	Active
U7l Bkt 18 Andrews Mt Hk 0/-9/10	137-0098	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamond Llcus W/Hk 0t +6a 018	350-1423	EUDAMEDFDA UDI	Class IIa	Active
Arch Ling Sst 16x16 Pk 10	206-0005	EUDAMEDFDA UDI	Class IIa	Active
Spark 35 R2 - Single Arch	728-3236-A	EUDAMED	Class IIa	Active
Upper Right Ultima Band Size 9	457-0009	EUDAMEDFDA UDI	Class IIa	Active
Twn Bkt Wedge Nar Lwr 1stbic-17trq018	170-0120	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultimax Band Size 6	457-0106	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 40arch 16x22lolgpk10	219-5308	EUDAMEDFDA UDI	Class IIa	Active
L4l Twin Db/Ul 22 Roth Nhk -1/-17/4	464-1044	EUDAMED	Class IIa	Active
Peerless Sgl 5deg Lfm-27trqx018 Lr	340-2216	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 30	654-0030	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ul 1st Bi -2t4a G-Off .022	349-8411	EUDAMEDFDA UDI	Class IIa	Active
Accent Bt 5sgl -22x22 F/Sm Ll	342-5121	EUDAMEDFDA UDI	Class IIa	Active
Peerless Mini-Term B/T-10t X 22 Ur	342-0014	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LS 016X022 NiTi DIMPLE 10PK	227-3251	EUDAMEDFDA UDI	Class IIa	Active
Compression Spring Niti 012x030 Pk3	221-5512	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Orange Closed Space	639-0046	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Lr 1st Bi G-Off/Hk-7t3a.022	455-1812	EUDAMEDFDA UDI	Class IIa	Active
U4/5l Nexus Clear Roth .022 -7/0/-2 Hk	437-4511	EUDAMEDFDA UDI	Class IIa	Active
L3l Damon Q .022 +13/+5/0 Super Tq	491-6435	EUDAMEDFDA UDI	Class IIa	Active
L5r Twin Bkt 22 Roth Nhk -1/-22/4	164-1086	EUDAMEDFDA UDI	Class IIa	Active
U1l Minitwin Db/Mtwin 18 Andrews 5/7	328-0121	EUDAMEDFDA UDI	Class IIa	Active
Wire Ligature P/F .009dia Pk 1000	270-0009	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Ntwn Ullat +14t +8a 018	350-0281	EUDAMEDFDA UDI	Class IIa	Active
L5l Twin Db/Ul 22 Andrews 2/-22	464-1028	EUDAMED	Class IIa	Active
U4&5r Minitwin Rec Db/Ul 22 Andrews Bhk 0/-7	429-1520	EUDAMEDFDA UDI	Class IIa	Active
L7r Ti B/T Orthos .018 -22/0/5	448-0205	EUDAMEDFDA UDI	Class IIa	Active
L5l Damon3 Mx .022 -17/+2/0	494-4451	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Customband-Lingual3	BL3	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Long Sz 3 .044 Dia.	200-0203	EUDAMEDFDA UDI	Class IIa	Active
U6l Tbt Bkt 2245 Roth Mt Hk 0/-14/14	137-0143	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 020x020 Nd Bulk 10pk	227-9114	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 17	652-0017	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 018dia Ll Pk10	205-6303	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Ndx-27tx018	512-2206	EUDAMEDFDA UDI	Class IIa	Active
Ling Assy Hinge Cap Ufm Lt Mesh 018	367-1616	EUDAMED	Class IIa	Active
Upper Left Second Molar Washbon Band Size 0	372-0000	EUDAMEDFDA UDI	Class IIa	Active

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Authorised Representatives

Kerr Italia Srl IT

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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.