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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 27 of 134

Device	Model / Reference	Registries	Class	Status
Orthos Cm Sst 018 X 025 Uplg Pk10	219-1411	EUDAMEDFDA UDI	Class IIa	Active
Honeydew Tma Baf.016x.022 Lo Sm Pk-5	211-5402	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 27	372-0027	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Db/Ul 22 Andrews Bhk Of/Gv 0/-17	429-1670	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 28	486-0028	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 30	374-0030	EUDAMEDFDA UDI	Class IIa	Active
Prls 10 Ufm Combi B/T - 0trq 18x45 Lt	195-0206	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 10	486-0010	EUDAMEDFDA UDI	Class IIa	Active
U7l Ti B/T Orthos/Damon .022 -27/0/6	449-1203	EUDAMEDFDA UDI	Class IIa	Active
U2l Damon Clear2 .022 -5/+9/0 Low Tq	497-6573	EUDAMEDFDA UDI	Class IIa	Active
Assy Orthos Cm Sgl 15ufm -10x22 Ul	189-0317	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 1	374-0001	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 014dia Ls Pk10	205-6101	EUDAMEDFDA UDI	Class IIa	Active
Niti Closed Coil 12mm Heavy Pk Of 10	704-6041	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Customband-Bracket1-Lingual4	BB1L4	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Sws Db/Om 22 M/G Hk And G-Off Bi 2/-7	339-2521	EUDAMEDFDA UDI	Class IIa	Active
C-Type Release Module/10 Pk Hvy Force	715-2021	EUDAMEDFDA UDI	Class I	Active
Universal Lower Second Bicuspid Band Size 13	330-0113	EUDAMEDFDA UDI	Class IIa	Active
CUNITI STRAIGHTWIRE 9 1/2LG-.016x.022 (ORAMETRIX	266-2105	EUDAMED	Class IIa	Active
L3l Twin Db/Mm 22 Andrews 5/-11	364-1074	EUDAMED	Class IIa	Active
Power Chain I Clear Wide 15ft Pkg Assy	639-0012	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 13	653-0013	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Trimline Band Size 20	480-0020	EUDAMEDFDA UDI	Class IIa	Active
L1l Ti-Orthos .018 -5/+2/0	448-6615	EUDAMEDFDA UDI	Class IIa	Active
Symetri Clear Mclaughlin, Bennett & Trevisi Upper 3-3 With Hooks On 3 .018	746-2103	EUDAMEDFDA UDI	Class IIa	Active
L4l Mtwnvs Db/Ul 18 Rth Nhk -1/-17/4	492-0611	EUDAMED	Class IIa	Active
U7r Bkt 22 Roth Mt Hk 0/-14/0	138-0191	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF US 016X022 NiTi DIMPLE 10PK	227-3328	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 31	653-0031	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 2	488-0002	EUDAMEDFDA UDI	Class IIa	Active
Prls Bond Tube 12 Upr Dbl-10 22x22 Lt	342-0535	EUDAMEDFDA UDI	Class IIa	Active
U3l Minitwin Db/Mtwin 18 Andrews 11/-7 Bhk	328-1321	EUDAMEDFDA UDI	Class IIa	Active
U3r Damon Q2 022 -9/+5/0 Low Tq	491-8882	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 25	653-0125	EUDAMEDFDA UDI	Class IIa	Active
U5 Alias Lingual .018 0/0/0	369-0050	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 3	332-0303	EUDAMEDFDA UDI	Class IIa	Active
NITI CR TRU-ARCH .016x.022 UPR MED-BP/100	210-0521	EUDAMEDFDA UDI	Class IIa	Active
U6l Ti B/T Orthos .018 -10/0/10	448-1201	EUDAMEDFDA UDI	Class IIa	Active
Peerless Sgl 5deg Fm 0trqx018lr/Ul	340-2226	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN XF US 018 NiTi ND 10PK	227-3387	EUDAMEDFDA UDI	Class IIa	Active
Twn Bkt Wedge Med Lwr Cus -11trq 022	170-0115	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 27 Baf .018 Dia L/L Pk10	205-0051	EUDAMEDFDA UDI	Class IIa	Active
Peerless 0deg Sgllfm-27trqx018 Ll	189-0306	EUDAMEDFDA UDI	Class IIa	Active
Mini Dmd Wick Wide-Lr Cent -5t +2a .018	350-3072	EUDAMEDFDA UDI	Class IIa	Active
Lingual Button Curved	610-0002	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Rec Db/Ul 18 Andrews 0/-17	428-0620	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower First Bicuspid Band Size 20	332-0120	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Twin Db/Ul 22 Andrews T1 0/-7/2	464-1091	EUDAMED	Class IIa	Active
Lower Left Ultimax Band Size 26	460-0126	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 7	489-0007	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.