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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 25 of 134

Device	Model / Reference	Registries	Class	Status
Mini Mesh Twn Ll2bi W/Hk -17t 0a 022	351-1723	EUDAMEDFDA UDI	Class IIa	Active
U2l Minitwin Db/Mtwin 22 Roth 9/8	329-0211	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Customband-Lingual2	BL2	EUDAMEDFDA UDI	Class IIa	Active
U3r Twin Db/Mm 18 Andrews 11/-7	363-1000	EUDAMED	Class IIa	Active
Mini-Diamnd Tw Urcus 1510320-7t+10a22	351-0320	EUDAMEDFDA UDI	Class IIa	Active
L5r Mtwnvs Db/Ul 18 Rth Dhk -1/-22/4	492-1710	EUDAMED	Class IIa	Active
L2l Damon Ultima 22 -1/4/0 Neutral Tq	333-3200	EUDAMEDFDA UDI	Class IIa	Active
Pref Arch Ni-Ti Upper .016 Small Pk10	205-0001	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Twn Lr1bi W/Hk -11t 0a 018	350-1612	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 1	488-0001	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 12	457-0012	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Short Sz 4 .044 Dia.	200-0224	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 8	435-0008	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .019x025up Lg Pk10	210-0935	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0035	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 8	457-0008	EUDAMEDFDA UDI	Class IIa	Active
Special- Prog. Dental Lo 2bi -22t	399-0001	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Up Sml 0160x0160 Pk/10	210-0706	EUDAMEDFDA UDI	Class IIa	Active
L4l Minitwin Rec Db/Ul 18 Andrews Bhk 0/-17	428-1621	EUDAMEDFDA UDI	Class IIa	Active
L2l Damon Q2 022 -3/+4/0 Std Tq	491-8821	EUDAMEDFDA UDI	Class IIa	Active
F/Bow Britegear Minshort#3 044 Pink	200-0343	EUDAMEDFDA UDI	Class IIa	Active
Arch Alxloop Tma 17x25 L/U 44mm Pk/5	206-0075	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 3	372-0003	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 32	378-0032	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 4	378-0004	EUDAMEDFDA UDI	Class IIa	Active
Accent Bt 5sgl Wdx -27x22 Lr	342-4231	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Lr 2nd Bi -9t3a022	455-0912	EUDAMEDFDA UDI	Class IIa	Active
L3l Symetri Clear Mclaughlin, Bennett & Trevisi .022 0/3/2	419-1411	EUDAMEDFDA UDI	Class IIa	Active
Ormco EtchFree Adhesive, Syringe Refill	740-0510	EUDAMEDFDA UDI	Class IIa	Active
Pref.ling.arch Ni-Ti Up.016 Sz1 Pk/10	205-0025	EUDAMEDFDA UDI	Class IIa	Active
Ortho Solo Refill (1 Bottle)	740-0271	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ur 1st Bi -6t0a018	454-0412	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 22 Roth G-Off 2bi -1/-22/4	339-0711	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon Ultima 22 Procline Tq	333-3420	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -32t 022 Wdx Ll	342-5337	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Lsm 5sgl Ndx -10tx18 R	515-0114	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 26	654-0026	EUDAMEDFDA UDI	Class IIa	Active
Alex.signature Bracket Lwr 1bi -7t 0a .018	154-3615	EUDAMED	Class IIa	Active
L1r Damon Q2 022 -3/+2/0 Std Tq	491-8810	EUDAMEDFDA UDI	Class IIa	Active
Prls Tpl 10 Upr Ging-10x22 0x22x45 Lt	193-0405	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 19	654-0119	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .016x022up Sm Pk10	210-0922	EUDAMEDFDA UDI	Class IIa	Active
L4l Mtwin Rec Bkt Flg 18 Rth Bhk 0/-17/4	163-2040	EUDAMED	Class IIa	Active
U4&5l Minitwin Db/Ul 18 Roth Bhk Of/Gv 0/-7/2	428-1573	EUDAMED	Class IIa	Active
U4&5l Sws Db/Om 18 M/G Hk Roth G-Off Bicuspid 0/-7/2	338-2511	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 4	489-0004	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Short Sz 3 .044 Dia.	200-0223	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 9	330-0109	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Wdx -27tx22 Lr	514-0231	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Short Sz 1 .044 Dia.	200-0221	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.