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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 26 of 134

Device	Model / Reference	Registries	Class	Status
Lower Left Second Molar Std High Retention Band Size 12	654-0012	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 23	377-0023	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 25	651-0025	EUDAMEDFDA UDI	Class IIa	Active
Arch P/F Edg.rect.lo.0170 X.0250 Pk10	209-1725	EUDAMEDFDA UDI	Class IIa	Active
L1&2r Mtwin Vs Db/Mtwin 18 And/Roth 2/-1	318-0020	EUDAMED	Class IIa	Active
Mini-Diamnd Tw Llcus 1510433 -7t+6a22	351-0433	EUDAMEDFDA UDI	Class IIa	Active
Prls Bond Tube 12 Upr Dbl-10 22x22 Rt	342-0435	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexander Sz 1 Lwr 16 Rd Pk 10	207-0030	EUDAMEDFDA UDI	Class IIa	Active
Accent Bt 5sgl Wdx -27x22 Ll	342-5231	EUDAMEDFDA UDI	Class IIa	Active
Assy Prls 10ufm Tpl 0x18x18x45 Occ-Lt	173-0428	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Minitwin Bkt Flng 22 Roth Nhk 0/-7/2	164-2035	EUDAMEDFDA UDI	Class IIa	Active
Diamond Wtwn Urcent 1110523 +14t+5a22	348-1021	EUDAMED	Class IIa	Active
Mini-Diamnd Tw Llcus 1510463 +7t+5a22	351-0463	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Univ G-Off Upr Bic -7t 0a .022	304-0515	EUDAMED	Class IIa	Active
Universal Upper Bicuspid Band With Lug Size 15	331-0315	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss 2keyloop Ll 30mm 016x022 Nd Bulk 10pk	227-5008	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Ls 017x025 Nd Ppak 10pk	227-9013	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ll 2nd Bi -8t6a G-Off .018	348-8911	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .019x025lo Sm Pk10	211-0925	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ul/Lr Wdx 0tx022	513-2101	EUDAMEDFDA UDI	Class IIa	Active
U1l Titanium Orthos Bios .022 +22/+5/0	449-8119	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ur Lat +9t 6a -3r .022	349-8210	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 12	459-0112	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Lr Cusp/Hk -2t 2a .022	349-9710	EUDAMEDFDA UDI	Class IIa	Active
Orthoscm Sst Arch .016 Dia Uplg Pk10	219-1590	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE UPPER 7x7 .018 SPK	740-0424	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Sws Db/Om 18 Roth G-Off Bicuspid 0/-7/2	338-0511	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LM 021X025 NiTi DIMPLE 10PK	227-3241	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Trimline Band Size 24	487-0024	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 29	654-0129	EUDAMEDFDA UDI	Class IIa	Active
L5l Twin Bkt 18 Roth Dbhk -1/-22/4	163-1037	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Q2 022 +11/+5/0 Hi Tq Hook	491-9885	EUDAMEDFDA UDI	Class IIa	Active
Mini Mesh Goff Lr 2bic Hk -22t 0a 018	350-1752	EUDAMEDFDA UDI	Class IIa	Active
Azura H.t. Wire 16x16 14in Lg Pk 10	266-0050	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Lfm Osgl Ndx -10tx22 R	514-0117	EUDAMEDFDA UDI	Class IIa	Active
F/Bow Britegear Minshort#4 044 Black	200-0644	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Niti Arch.019x.025losm Pk10	219-3112	EUDAMEDFDA UDI	Class IIa	Active
Unidose Gun	740-0200	EUDAMEDFDA UDI	Class I	Active
Arch Tma Rev.curve Upr .016x022 Pk/10	215-0003	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 14	651-0014	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band Size 31	331-0131	EUDAMEDFDA UDI	Class IIa	Active
U1r Damon Clear2 .022 +22/+5/0 High Tq	497-6566	EUDAMEDFDA UDI	Class IIa	Active
L3l Sws Db/Om 22 Roth Cuspid 7/-11/2	339-0411	EUDAMEDFDA UDI	Class IIa	Active
Arch Alxloop Tma 17x25 M/U 38mm Pk/5	206-0072	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Std High Retention Band Size 10	651-0110	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Round.0200 Lo Sml Pk/20	211-0030	EUDAMEDFDA UDI	Class IIa	Active
U6l Udbt Db/Ul 22 Roth Mthk No Hgtube 0/-14/14	438-0174	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Super Short Sz 2 .044 Dia	200-0262	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Round.0180 Lo Lge Pk/20	211-0128	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Posted 32mm Um 020 Nd Bulk 10pk	227-7029	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.