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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 133 of 134

Device	Model / Reference	Registries	Class	Status
Upper Left First Molar Std High Retention Band Size 15	652-0115	EUDAMEDFDA UDI	Class IIa	Active
Mini-V Diam Ul Cent Std +14t +5a 018	350-6131	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ll 2nd Bi -8t6a G-Off .022	349-8911	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Tw Ulcen 1500141 +22t+5a18	350-0141	EUDAMEDFDA UDI	Class IIa	Active
L4r Attract Db/Am 22 Roth -1/-17/4	364-7053	EUDAMED	Class IIa	Active
Orthos C/M-Ul 2nd Bi G-Off/Hk -8t4a018	454-1511	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 8	373-0008	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 18	459-0118	EUDAMEDFDA UDI	Class IIa	Active
Orth Accent Lfm 0 Sgl-10x 018 Rt Ndx	340-4118	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Customband-Bracket1-Lingual1	BB1L1	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2251 Andrews Hk Fcc 0/-9/10	137-0077	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon Q2 G-Off 022 -12/+4/0 Std Tq - Hook	491-9941	EUDAMEDFDA UDI	Class IIa	Active
U2r Damon Q2 022 -5/+9/0 Low Tq	491-8872	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Tma Lo Lrg 016x022 Pk/10	207-0044	EUDAMEDFDA UDI	Class IIa	Active
L3r Attract Db/Am 22 Andrews Bhk 5/-11	364-7050	EUDAMED	Class IIa	Active
Mini-Diamond Urcus W/Hk -7t +10a 022	351-1320	EUDAMEDFDA UDI	Class IIa	Active
Alex.signature Bracket Ur Cusp -3t 10a 018	154-3310	EUDAMED	Class IIa	Active
U1l Sws Db/Om 22 Andrews Central 5/7	339-0121	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .020x.020-Uplg Pk10	210-0937	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 40 Baf.019x.025up Lg Pk10	210-0955	EUDAMEDFDA UDI	Class IIa	Active
Alex.signature Bracket 1bi Unv -6t 0a 018	154-3510	EUDAMED	Class IIa	Active
TRU-ARCH ALGN SE200 UM 16X16 NiTi ND 10PK	227-3134	EUDAMEDFDA UDI	Class IIa	Active
L6r Bkt 18 Mt Hk Bal 0/-10	138-0132	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Wdx-32tx022	512-2107	EUDAMEDFDA UDI	Class IIa	Active
Twn Bkt Wedge Med Upr Cus&Bic-7trq022	170-0109	EUDAMEDFDA UDI	Class IIa	Active
L1&2l Mtwn Rec Db/Mtwn 18 And/Rth 0/-1 Bhk	328-1021	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 2251 Andrews Mt Hk 5/-9/10	138-0081	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ll Central -5t 2a .022	455-0615	EUDAMEDFDA UDI	Class IIa	Active
Orthos Lsm 6dg -10t B/T Wdx Lr .022	342-5157	EUDAMEDFDA UDI	Class IIa	Active
UP/LO4&5 UNIV STb STRAIGHTWIRE HK .018 +11/0/0	369-3402	EUDAMEDFDA UDI	Class IIa	Active
L5l Damon Q2 G-Off 022 -17/+4/0 Std Tq	491-8951	EUDAMEDFDA UDI	Class IIa	Active
Orthosc/M-Ul 2nd Bi G-Off -8t 4a .022	455-0511	EUDAMEDFDA UDI	Class IIa	Active
U7r Bkt 22 Andrews Mt Hk 5/-9/10	138-0169	EUDAMEDFDA UDI	Class IIa	Active
U3l Attract Db/Am 22 Andrews 11/-7	364-7025	EUDAMED	Class IIa	Active
Tru-Arch Ss Ls 017x022 Nd Ppak 10pk	227-9012	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 10	654-0010	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 7	373-0007	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 5	654-0005	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 19	376-0019	EUDAMEDFDA UDI	Class IIa	Active
L6r Bkt 22 Andrews T2 Hk Cap -1/-30/4	138-0205	EUDAMED	Class IIa	Active
U6r Bkt 22 Roth Ss Mt Hk 0/-14/14	138-0011	EUDAMEDFDA UDI	Class IIa	Active
L6r Dbt Bkt 22 Andrews Hk Cap 2/-30	138-0241	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 9	651-0009	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 23	371-0023	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 19x25uplgpk10	219-4412	EUDAMEDFDA UDI	Class IIa	Active
Protech Glass Ion.cemkit-Intro 2-1210	740-0155	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP35D 019x025LS PK10	211-9115	EUDAMEDFDA UDI	Class IIa	Active
Orthos Lsm 6dg -10t B/T Ndx Lr .022	342-6157	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band With Lug Size 28	331-0328	EUDAMEDFDA UDI	Class IIa	Active
L6r Db/Ul 22 Andrews T2 Hk Fcc -1/-30/4	438-0006	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.