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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 18 of 134

Device	Model / Reference	Registries	Class	Status
U6l Accent Mini Mbt .022 -14/0/+10	342-1365	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN SE200 LM 17X25 NiTi ND 10PK	227-3112	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN SE200 LM 18X25 NiTi ND 10PK	227-3116	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ur Cusp/Hk 0t 8a -4r .018	348-9310	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Minitwin Db/Ul 18 Of/Gv Andrews 0/-7	428-0571	EUDAMEDFDA UDI	Class IIa	Active
Damon Sl Align Se200 016 Dimple Ppak 10pk	227-1006	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 019x025 Nd Ppak 10pk	227-9006	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Mtwn Uni Bi 0t0a.018	303-0504	EUDAMED	Class IIa	Active
U3l Damon3 Mx .022 +7/+6/0 Hi Tq	494-4483	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 25	489-0025	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg 0t 018 Wdx Ul/Lr	340-4807	EUDAMEDFDA UDI	Class IIa	Active
Prls 2ndmol B/T 12deg -10t 018 Ndx Ur	517-2104	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 8	488-0008	EUDAMEDFDA UDI	Class IIa	Active
Prls 2ndmol B/T 12deg -10t 022 Wdx Ur	517-2203	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultimax Band Size 10	457-0110	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 16x22losmpk10	219-4108	EUDAMEDFDA UDI	Class IIa	Active
L6r Dbt Bkt 22 Andrews Hk Fcc 2/-30	138-0243	EUDAMED	Class IIa	Active
Lower Right First Molar Washbon Band Size 4	373-0004	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 12	488-0012	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 22	486-0022	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 2245 Andrews Nhk Cap 5/-9/10	138-0037	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Ndx -27tx22 Lr	514-0131	EUDAMEDFDA UDI	Class IIa	Active
Opt Mini-Dimnd-Wick Ur Cuspid -3t+10a 018	350-3310	EUDAMEDFDA UDI	Class IIa	Active
L1&2l Mtwin Vs Db/Mtwin 18 And/Roth 2/-1	318-0021	EUDAMED	Class IIa	Active
Lower Left First Molar Trimline Band Size 16	435-0016	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultima Band Size 28	458-0028	EUDAMEDFDA UDI	Class IIa	Active
Wire 14in Tripleflex .0150 Dia Pk/10	264-0150	EUDAMEDFDA UDI	Class IIa	Active
Orthos Burst Llcusp Bkt/Tube -6t+6a 022	351-9403	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LS 019X025 NiTi DIMPLE 10PK	227-3267	EUDAMEDFDA UDI	Class IIa	Active
U3r Damon Clear 2 .022 +7/+5/0 Std Tq Hk	497-7580	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 7	371-0007	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 13	376-0013	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Db/Ul18 Andrews Bhk 0/-22	428-1720	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2245 Andrews Hk Fcc 5/-9/10	137-0021	EUDAMEDFDA UDI	Class IIa	Active
Orthos Lsm 6dg -10t B/T Ndx Ll .018	513-2220	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 17	378-0017	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 3	653-0103	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Odbl Lfm -10x22x21 Rt	520-0237	EUDAMEDFDA UDI	Class IIa	Active
U1l Attract Db/Am 18 Roth 5/12	363-7017	EUDAMED	Class IIa	Active
Facebow S/R Mini-Vec Sz 3 .050 Dia	200-0253	EUDAMEDFDA UDI	Class IIa	Active
Mini-V Mesh L2 Bic Thn -17t 0a 018	350-6725	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Bkt-Ur Lat -4.5r +9t 9a 018	454-0210	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Damon Clear .022 -11/+2/0 Hk Std Tq	497-7490	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 10	330-0110	EUDAMEDFDA UDI	Class IIa	Active
L3l Minitwin Db/Mtwin 18 Roth 7/-11/2 Bhk	328-1411	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 19	653-0119	EUDAMEDFDA UDI	Class IIa	Active
L5r Symetri Clear Mclaughlin, Bennett & Trevisi .022-17/2/0 W/Hook	419-2710	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Assembly Ll Cus 7t6a .018	348-6719	EUDAMEDFDA UDI	Class IIa	Active
Ling.hrt.assy.upr Lat Rt .018	367-5002	EUDAMED	Class IIa	Active
F/Bow Britegear Short #3 044 Yellow	200-0423	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

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.