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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 16 of 134

Device	Model / Reference	Registries	Class	Status
Orthos Lsm 6dg -10t B/T Ndx Ll .018	340-6057	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 40arch 16x22upsmpk10	219-5208	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon Q .022 -12/+4/0 Std Tq	491-6441	EUDAMEDFDA UDI	Class IIa	Active
L4r Attract Db/Am 18 Andrews Bhk 2/-17	363-7051	EUDAMED	Class IIa	Active
Pref.ling.arch Ni-Ti Up.018 Sz1 Pk/10	205-0026	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Db/Ul 22 Andrews T1 0/-7/2	464-1081	EUDAMED	Class IIa	Active
Arch D-Rect Braided Lwr 021x025	201-0015	EUDAMEDFDA UDI	Class IIa	Active
Peerlss 5deg Lip Bumpr -25x018x045 Lt	175-0102	EUDAMEDFDA UDI	Class IIa	Active
U6r Obt Bkt 1845 Andrews Hk Fcc 0/-9/10	138-0050	EUDAMED	Class IIa	Active
U3r Damon Q2 022 +7/+5/0 Std Tq	491-8880	EUDAMEDFDA UDI	Class IIa	Active
U1r Sws Db/Om 18 Super Torque Central 5/17	338-0140	EUDAMEDFDA UDI	Class IIa	Active
Orthosc/M-Ul 1st Bi G-Off -6t 0a .018	454-0411	EUDAMEDFDA UDI	Class IIa	Active
U1l Damon Q .022 +15/+5/0 Std Tq	491-6461	EUDAMEDFDA UDI	Class IIa	Active
L4l Sws Db/Om 18 Roth G-Off 1bi -1/-17/4	338-0611	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 21	488-0021	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Sws Db/Om 22 M/G Hk Roth Non G-Off 0/-7/2	339-2531	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Short Sz 5 .044 Dia.	200-0225	EUDAMEDFDA UDI	Class IIa	Active
L5l Twin Bkt 18 Andrews Dbhk 2/-22	163-1036	EUDAMEDFDA UDI	Class IIa	Active
Zoo Master Pack 6d 1/2 M/H Donkey	630-0035	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 1845 Andrews Mt Hk 0/-9/10	137-0018	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Rose Open Space	639-0051	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 32	374-0032	EUDAMEDFDA UDI	Class IIa	Active
Prls 15 Ufm Combi B/T -10trq 22x51 Lt	195-0211	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 4	377-0004	EUDAMEDFDA UDI	Class IIa	Active
U3l Minitwin Db/Mtwin 22 Spec 9/-2/4	329-0351	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band With Lug Size 14	330-0314	EUDAMEDFDA UDI	Class IIa	Active
DAMON ULTIMA ARCHWIRE SST 10PK - 210 x 275	227-1274	EUDAMEDFDA UDI	Class IIa	Active
U2r Symetri Clear Mclaughlin, Bennett & Trevisi .018 +10/8/0	418-1210	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Db/Ul 22 Roth 0/-22/4	429-0710	EUDAMEDFDA UDI	Class IIa	Active
U4 & 5l Sws Db/Om 22 Roth Non G-Off 0/-7/2	339-0531	EUDAMEDFDA UDI	Class IIa	Active
L4l Mtwnvs Db/Ul 18 Rth Dbk -1/-17/4	492-1611	EUDAMED	Class IIa	Active
U4&5r Attract Db/Am 18 Roth 0/-7/2	363-7071	EUDAMED	Class IIa	Active
U1l Damon Q2 022 +22/+5/0 Hi Tq	491-8867	EUDAMEDFDA UDI	Class IIa	Active
ORTHOS CM CUNITI 35ARCH 17x17 UPSM PK/10	219-4209	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Twn Lr1bi W/Hk -17t 0a 018	350-1622	EUDAMEDFDA UDI	Class IIa	Active
Damon Align Se200 014 Nd Ppak 10pk	227-1003	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Us 014 Nd Ppak 10pk	227-9042	EUDAMEDFDA UDI	Class IIa	Active
L6r Bkt 18 Andrews Hk Fcc 2/-30	138-0152	EUDAMEDFDA UDI	Class IIa	Active
Damon Cuniti W/Stops .014 Dia. Pk10	205-1902	EUDAMEDFDA UDI	Class IIa	Active
Mtw Bkt Wdg Cus/Bic W/Hk -7t 018 Ur	170-0710	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 7	376-0007	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 27	651-0027	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Ll 1st Bi -11t 0a 18	303-0613	EUDAMED	Class IIa	Active
L5r Sws Db/Om 18 D/G Hk Roth G-Off 2bi -1/-22/4	338-1710	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Washbon Band Size 19	375-0019	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent 15dbl Ufm -10x22x21 Lt	521-0239	EUDAMEDFDA UDI	Class IIa	Active
Mini-V Mesh L1 Bic Thn -11t 0a 022	351-6615	EUDAMEDFDA UDI	Class IIa	Active
Power O Powder Blue .120 Pk/1000	640-0155	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 32	652-0132	EUDAMEDFDA UDI	Class IIa	Active
L1r Ti-Orthos .022 -5/+2/0	449-6610	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.