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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 131 of 134

Device	Model / Reference	Registries	Class	Status
U4 & 5r Sws Db/Om 22 Andrews Non G-Off 2/-7/0	339-0540	EUDAMEDFDA UDI	Class IIa	Active
Damon Ss Posted 34mm 16x25 Nd Bulk10pk	227-1036	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 6	372-0006	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 25	330-0125	EUDAMEDFDA UDI	Class IIa	Active
U2l Titanium Orthos Bios .018 +14/+9/0	448-8217	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 30	459-0130	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultimax Band Size 17	460-0117	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 018dia Us Pk10	205-6203	EUDAMEDFDA UDI	Class IIa	Active
Orth Accent Lsm 5sgl -10x.022 Rt Wdx	342-5213	EUDAMEDFDA UDI	Class IIa	Active
L4l Twin Db/Ul 22 Andrews T2 Pa 5/-17/4	464-1049	EUDAMED	Class IIa	Active
U2r Attract Db/Am 22 Andrews 9/3	364-7007	EUDAMED	Class IIa	Active
U6r Tbt Db/Ul 2245 Andrews Mt Hk 0/-9/10	438-0064	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -10t 018 Wdx Ur	340-5047	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm B/T Lfm Osgl -10x018 Lt	340-2356	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .021x.025uplg Pk10	210-0936	EUDAMEDFDA UDI	Class IIa	Active
Advansync 2 Telescoping Mechanism Assy, Left Pk5	600-4240	EUDAMEDFDA UDI	Class IIa	Active
Prls 10 Ufm Combi B/T -10trq 22x51 Lt	195-0203	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Ls 020 Nd Ppak 10pk	227-9027	EUDAMEDFDA UDI	Class IIa	Active
L3r Sws Db/Om 18 Roth Cuspid 7/-11/2	338-0410	EUDAMEDFDA UDI	Class IIa	Active
U1r Damon Q .022 +22/+5/0 Super Tq	491-6466	EUDAMEDFDA UDI	Class IIa	Active
Sheath Ul/Lr W/2.2mm Mg Ball Hk 36x72	676-3673	EUDAMEDFDA UDI	Class IIa	Active
U6l Obt Bkt 2245 Andrews Hk Fcc 0/-9/10	137-0101	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 18 Roth G-Off 2bi -1/-22/4	338-0710	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 26	486-0026	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm B/T Ufm 15sgl -10x022lt	342-2359	EUDAMEDFDA UDI	Class IIa	Active
L6l Db/Ul 22 Andrews T2 Hk N/Cap -1/-30/4	438-0107	EUDAMED	Class IIa	Active
Mini2000 Dmd Twn Urlat/Thk +7t +8a 22	304-0250	EUDAMED	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0008	EUDAMEDFDA UDI	Class IIa	Active
Peerless Tpl 10ufm-10x22 0x18x45 Hklt	173-0423	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Tma Lo Lrg 017x025 Pk/10	207-0047	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Green Closed Space	639-0043	EUDAMEDFDA UDI	Class IIa	Active
15 Degree Micro Mini Ligature Cutter	800-1000	EUDAMED	Class I	Active
Lower Left Second Molar Washbon Band Size 29	376-0029	EUDAMEDFDA UDI	Class IIa	Active
Diamond Mtw Llcus 1700439 -7t+6a022hk	348-1328	EUDAMED	Class IIa	Active
Niti Closed Coil 9mm Heavy Pk Of 10	704-6039	EUDAMEDFDA UDI	Class IIa	Active
U6l Tbt Bkt 2251 Andrews Mt Hk 0/-9/10	137-0149	EUDAMEDFDA UDI	Class IIa	Active
Ni-Ti Broad Arch Lolge 0175 0175 Pk10	211-0511	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP27D 014x025UL PK10	210-9201	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 22	372-0022	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Damon Q2 022 -11/+2/0 Std Tq - Hook	491-9890	EUDAMEDFDA UDI	Class IIa	Active
Mini Mesh Goff Lr 2bic Hk -17t 0a 022	351-1742	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 25	435-0025	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 14	653-0014	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 40arch 19x25upsmpk10	219-5212	EUDAMEDFDA UDI	Class IIa	Active
Miniwick Wide Ll Lat Whk -5t +6a 018	350-4063	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Mini-Vec Sz 5 .044 Dia	200-0245	EUDAMEDFDA UDI	Class IIa	Active
L6l Bkt 22 Roth Ss Mt Hk -1/-30/4	137-0221	EUDAMEDFDA UDI	Class IIa	Active
L4r Damon Q .022 -12/+4/0 Std Tq	491-6440	EUDAMEDFDA UDI	Class IIa	Active
COPPER NiTi 35 BAF 17x17 LOSM PK/10	211-0921	EUDAMEDFDA UDI	Class IIa	Active
U6l Obt Db/Ul 2245 Andrews Mt Hk 5/-9/10	438-0159	EUDAMED	Class IIa	Active

Related Companies

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Kerr Italia Srl IT

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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.