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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 128 of 134

Device	Model / Reference	Registries	Class	Status
Accent Bt 5sgl Wdx -10x18 Usm Lt	340-5212	EUDAMEDFDA UDI	Class IIa	Active
U3l Titanium Orthos Bios M-G Hk .018 +7/+10/0	448-9319	EUDAMEDFDA UDI	Class IIa	Active
Damon Sl Align Se200 012 Dimple Ppak 10pk	227-1000	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 28	374-0028	EUDAMEDFDA UDI	Class IIa	Active
Mini Wick Wdll Latw/Hk-5t6a 18	350-4053	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 15	435-0015	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Up/Lo 5x5 La Mod-.022	740-0301	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 26	651-0026	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2245 Andrews Hk Cap 0/-9/10	137-0015	EUDAMEDFDA UDI	Class IIa	Active
U6l Obt Bkt 2245 Roth Mt Hk 0/-14/14	137-0115	EUDAMEDFDA UDI	Class IIa	Active
Opt Mini-D Wick Ll Cuspid -7t +6a 022	351-3343	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Sws Db/Om 22 D/G Hk Andrews Non G-Off 2/-7/0	339-2542	EUDAMEDFDA UDI	Class IIa	Active
Damon Tieback Module Sz 1 Gray Pk40	637-0011	EUDAMEDFDA UDI	Class IIa	Active
Orth Accent Lsm 5sgl -10x.018 Rt Wdx	340-5214	EUDAMEDFDA UDI	Class IIa	Active
U3r Sws Db/Om 18 Hk Roth Cuspid 13/-2/4	338-1310	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0021	EUDAMEDFDA UDI	Class IIa	Active
740-0522	740-0522	EUDAMED	Class I	Active
U6r Cbt Db/Ul 2245 Andrews Mt Hk 5/-9/10	438-0040	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Clear2 .022 +11/+5/0 Hook High Tq	497-7585	EUDAMEDFDA UDI	Class IIa	Active
Color Master Pack - 5f 3/8 Buffalo	636-0128	EUDAMEDFDA UDI	Class IIa	Active
L6r Sl B/T Orthos .022 Flg -22/0/0	513-1252	EUDAMEDFDA UDI	Class IIa	Active
Mini Mesh Tw L1bi 1510615 -11t0a022	351-0615	EUDAMEDFDA UDI	Class IIa	Active
Damon Ss Posted 32mm 19x25 Nd Bulk10pk	227-1035	EUDAMEDFDA UDI	Class IIa	Active
Spiritmb Up/Lo 5x5 La Mod-.018	740-0227	EUDAMEDFDA UDI	Class IIa	Active
U3r Attract Db/Am 22 Roth 13/-2/4	364-7001	EUDAMED	Class IIa	Active
U6r Db/Ul 22 Andrews Hk Fcc 0/-9/10	438-0052	EUDAMED	Class IIa	Active
Upper Right Ultimax Band Size 22	457-0122	EUDAMEDFDA UDI	Class IIa	Active
U1r Titanium Orthos Bios .018 +22/+5/0	448-8118	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 27 Baf .019x.025l/L Pk10	211-0915	EUDAMEDFDA UDI	Class IIa	Active
L4r Damon Ultima G-Off 22 -12/4/0 Neutral Tq	333-4406	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 10	373-0010	EUDAMEDFDA UDI	Class IIa	Active
L4l Sws Db/Om 22 D/G Hk Roth Non G-Off -1/-17/4	339-1631	EUDAMEDFDA UDI	Class IIa	Active
Labial Hemispherical Hook 1-1010	242-0004	EUDAMEDFDA UDI	Class IIa	Active
U2l Twin Db/Mm 22 Set Iii/Roth 9/8	364-1043	EUDAMED	Class IIa	Active
Vectortas Crimpable Post Pk6	601-0040	EUDAMEDFDA UDI	Class IIa	Active
Power Thread Gray 025dia 50ft Spool	640-2025	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Silver Closed Space	639-0064	EUDAMEDFDA UDI	Class IIa	Active
U4, 5r Damon Ultima 22 Procline Tq	333-1420	EUDAMEDFDA UDI	Class IIa	Active
U6l Tbt Bkt 2245 Andrews Mt Hk 5/-9/10	137-0137	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Lo Lge 0160x0220 Pk/10	211-0711	EUDAMEDFDA UDI	Class IIa	Active
U3l Sws Db/Om 18 Roth Cuspid 13/-2/4	338-0311	EUDAMEDFDA UDI	Class IIa	Active
U3l Attract Db/Am 18 Roth Bhk 13/-2/4	363-7027	EUDAMED	Class IIa	Active
L5r Twin Bkt 18 Andrews 2/-22	163-1060	EUDAMEDFDA UDI	Class IIa	Active
Peerless G-Off Ufm -10t 15do .022 Rt	342-2010	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2251 Andrews Mt Hk 5/-9/10	137-0081	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Ulcuspid 0t +10a 18	303-0331	EUDAMED	Class IIa	Active
Crown W/Cutout-Advansync 2 L6r Size 7 Pk5	600-4337	EUDAMEDFDA UDI	Class IIa	Active
Mini-Twist Kobayashi Hook .012 Pk/100	271-0000	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0025	EUDAMEDFDA UDI	Class IIa	Active
Mini Diam Ntwn Thk Urlat +7t +8a 022	351-0270	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

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.