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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 132 of 134

Device	Model / Reference	Registries	Class	Status
DAMON NiTi 38mm PRE-TRQ 20 DEG 017 X 025 PK5	227-0382	EUDAMEDFDA UDI	Class IIa	Active
U6l Accent Mini Damon .022 -18/0/+12	513-0163	EUDAMEDFDA UDI	Class IIa	Active
Optixrt Tw Loant 1500015 0t 0a 018	350-0015	EUDAMEDFDA UDI	Class IIa	Active
Refill Syringe-Blugloo	740-0272	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band Size 19	331-0119	EUDAMEDFDA UDI	Class IIa	Active
Assy Prls 5lfm Dbl 0x18x18 Lt	171-0432	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn/Hk Ll 2 Bi -17t 0a 18	303-1723	EUDAMED	Class IIa	Active
Upper Left Ultima Band Size 33	458-0033	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE CUNITI .014 DIA LG PK10	204-2133	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 1845 Andrews Mt Hk 5/-9/10	137-0020	EUDAMEDFDA UDI	Class IIa	Active
L4l Attract Db/Am 18 Andrews Bhk 2/-17	363-7035	EUDAMED	Class IIa	Active
5-5 U/L Damon Q Single Patient Kit: U2-2 Low	740-1401	EUDAMEDFDA UDI	Class IIa	Active
Prlss 12upper Double Bt-10x22x22 Rt	172-0435	EUDAMEDFDA UDI	Class IIa	Active
L3l Minitwin Db/Mtwin 22 Andrews 5/-11	329-0421	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 20	377-0020	EUDAMEDFDA UDI	Class IIa	Active
L6l Ltbt Bkt 1845 Roth Mt Hk -1/-30/4	137-0186	EUDAMEDFDA UDI	Class IIa	Active
ORTHOS CM CuNiTi DIMP ARCH 35DEG 19X25 LOSM PK10	219-7307	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Sst Arch 018x025 Lolg Pk10	219-1311	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg 0t 018 Ndx Ul/Lr	340-6807	EUDAMEDFDA UDI	Class IIa	Active
Opt Mini-Dimnd-Wick Lr Cuspid -7t +6a 018	350-3342	EUDAMEDFDA UDI	Class IIa	Active
F/Bow Britegear Short #4 044 Pink	200-0324	EUDAMEDFDA UDI	Class IIa	Active
5-5 U/L Damon Clear 2, Damon Clear & Damon Q Single Patient Kit: Std-Tq	740-1408	EUDAMEDFDA UDI	Class IIa	Active
Accent Bt 5sgl -10x18 Usm Rt	340-4112	EUDAMEDFDA UDI	Class IIa	Active
Color Master Pack - 4f 5/16 Moose	636-0127	EUDAMEDFDA UDI	Class IIa	Active
L5l Titanium Orthos Bios .018 -17/+3/0	448-8917	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 UM 014 NiTi ND 10PK	227-3152	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Damon Clear .022 -11/+2/0 Hk Std Tq	497-7491	EUDAMEDFDA UDI	Class IIa	Active
Peerless Mini-Term B/T Ot X 18 Ul/Lr	340-0011	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Trimline Band Size 15	487-0015	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP27D 016x025US PK10	210-9102	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl 2nd Wdx -10tx22 Ur	514-0211	EUDAMEDFDA UDI	Class IIa	Active
U3l Minitwin Db/Mtwin 18 Roth Surg 0/-2/4 Bhk	328-1317	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 15	377-0015	EUDAMEDFDA UDI	Class IIa	Active
Prls 0 Ufm Combi B/T 0trq 18x45 Lt	195-0208	EUDAMEDFDA UDI	Class IIa	Active
Color Master Pack - 3e 1/4 Bear	636-0122	EUDAMEDFDA UDI	Class IIa	Active
Minidiamd Tw Ullat Thk1500241+3t+8a18	350-0241	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Um 018 Nd Ppak 10pk	227-9040	EUDAMEDFDA UDI	Class IIa	Active
Peerless 0deg Sgllfm-27trqx018 Lr	190-0306	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 17	371-0017	EUDAMEDFDA UDI	Class IIa	Active
Prls 5deg Tpl Bt Lfm .27tx22x45dia Lt	171-0871	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP35D 020x020LS PK10	211-9112	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 21	376-0021	EUDAMEDFDA UDI	Class IIa	Active
U3l Alias Lingual .018 +60/+08/+06	369-0031	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Bkt 18 Andrews Spec 0/-7	163-1005	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 14	652-0014	EUDAMEDFDA UDI	Class IIa	Active
U6l Tbt Bkt 2245 Andrews Mt Hk 0/-9/10	137-0135	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 20	374-0020	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon Q2 G-Off 022 -5/+4/0 Hi Tq - Hook	491-9943	EUDAMEDFDA UDI	Class IIa	Active
Power Chain White Open Space	639-0038	EUDAMEDFDA UDI	Class IIa	Active
Peerless 0deg Sgllfm-22trqx018 Ll	189-0304	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.