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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 29 of 134

Device	Model / Reference	Registries	Class	Status
Purple Tma Baf .016x.022 Lo Sm Pk-5	211-4402	EUDAMEDFDA UDI	Class IIa	Active
U5r Twin Db/Ul 22 Andrews T3 Pa -2/-7/6	464-1003	EUDAMED	Class IIa	Active
Optiband Ultra, 5 Syringe Kit, Blue Color 2-1491	740-0293	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 6	489-0006	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN SE200 LM 19X25 NiTi ND 10PK	227-3118	EUDAMEDFDA UDI	Class IIa	Active
Spark 15 - Reorder	728-3215-R	EUDAMED	Class IIa	Active
U2r Ti-Orthos .018 +9/+9/-4.5	448-6210	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 27	460-0027	EUDAMEDFDA UDI	Class IIa	Active
U3r Mtwnvs Sr Db/Mtwin 22 Rth 13/-2/4	319-0310	EUDAMED	Class IIa	Active
Lower Right Ultimax Band Size 14	459-0114	EUDAMEDFDA UDI	Class IIa	Active
Prls Ormesh 2nd B/T 12deg -10t 018 Ul	340-0556	EUDAMEDFDA UDI	Class IIa	Active
Alex Signature Mesh W/Hook-Ll Lateral -5t +6a .018	354-4063	EUDAMEDFDA UDI	Class IIa	Active
L3l Minitwin Db/Mtwin 22 Roth 7/-11/2	329-0411	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Posted 34mm Um 018x025 Nd Bulk 10pk	227-7032	EUDAMEDFDA UDI	Class IIa	Active
Opt Mini Wick Wide Lo Ant -1t0a 022	351-3045	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss 2keyloop Ls 22mm 019x025 Nd Bulk 10pk	227-5001	EUDAMEDFDA UDI	Class IIa	Active
L7r Ti B/T Orthos .022 -22/0/5	449-0205	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Black Closed Space	639-0042	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ul 2nd Bi /hk -8t4a018	454-1513	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Twn Lr2bi W/Hk -17t 0a 018	350-1722	EUDAMEDFDA UDI	Class IIa	Active
U7l Ubbt Db/Ul 18 Bioprog Mt 0/-10/12	437-0151	EUDAMED	Class IIa	Active
U2l Damon3 Mx .022 +3/+9/0 Lo Tq	494-4473	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Minitwin Db/Ul 18 Roth 0/-7/2	428-0511	EUDAMEDFDA UDI	Class IIa	Active
Alex Signature Mesh Assy Ll Cusp -7t+6 018	354-3343	EUDAMEDFDA UDI	Class IIa	Active
U6l Bkt 22 Andrews Hk Fcc 5/-9/10	137-0003	EUDAMEDFDA UDI	Class IIa	Active
U6r Bkt 22 Andrews Hk Fcc 0/-9/10	138-0001	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 32	488-0032	EUDAMEDFDA UDI	Class IIa	Active
L1r Damon Q2 022 -6/2/0 Std/Low Tq	491-8816	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Llcus 1510433w/Hk-7t+6a022	351-1433	EUDAMEDFDA UDI	Class IIa	Active
Minidiamond Twn Ur Lat W/Hk +7t+8a018	350-1250	EUDAMEDFDA UDI	Class IIa	Active
Power O Short Stick .120 Green Pack1000	640-1246	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Mtwin L 1bi 1700214 -17t 0a 18	340-1504	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 21	435-0021	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Bkt-Ll Cus -4.5r -6t 6a 022	455-0711	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 15	373-0015	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Lr 2nd Bi -9t3a .018	454-0912	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower First Bicuspid Band Size 17	332-0117	EUDAMEDFDA UDI	Class IIa	Active
L6r Dbt Db/Ul 22 Roth Mt Hk -1/-30/4	438-0019	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Damon Q2 G-Off 022 -11/+2/0 Std Tq	491-8990	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF UM 018X025 NiTi DIMPLE 10PK	227-3304	EUDAMEDFDA UDI	Class IIa	Active
L5r Ti-Orthos G-Off .022 -9/+3/0	449-6910	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ll 1st Bi G-Off/Hk-7t3a.022	455-1813	EUDAMEDFDA UDI	Class IIa	Active
U6r Db/Ul 18 Roth Ss Mt Hk 0/-14/14	437-0034	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 28	373-0028	EUDAMEDFDA UDI	Class IIa	Active
Arch Rev.curve Niti Up.016 X.022 Pk10	216-1622	EUDAMEDFDA UDI	Class IIa	Active
DAMON ULTIMA ARCHWIRE CuNiTi W/STOPS 10PK - .0190 x .0275	227-1164	EUDAMEDFDA UDI	Class IIa	Active
U2l Sws Db/Om 18 Super Torque Lateral 9/10	338-0241	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Lr Cus W/Mesial Hk +7t 6a .018	348-7718	EUDAMEDFDA UDI	Class IIa	Active
Diamond Mtwn Ullat 1120421 +7t+8a 022	348-1122	EUDAMED	Class IIa	Active
L5r Twin Db/Ul 22 Andrews T3 Pa -2/-22/6	464-1077	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.