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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 120 of 134

Device	Model / Reference	Registries	Class	Status
Lower Right Ultima Band Size 24	459-0024	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 21	651-0021	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ul 2nd Bi -3t6a G-Off .018	348-8511	EUDAMEDFDA UDI	Class IIa	Active
L4r Sws Db/Om 22 Roth Non G-Off -1/-17/4	339-0630	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Tweed L Ant 1700237 0t 0a 022	342-0511	EUDAMEDFDA UDI	Class IIa	Active
Purple Tma Baf .016x.022 Up Sm Pk-5	210-4402	EUDAMEDFDA UDI	Class IIa	Active
Ext. Spring Hvy Niti-010x030 Pk 10	222-5620	EUDAMEDFDA UDI	Class IIa	Active
L7r Accent Mini Mbt .022 -10/0/+5	342-1376	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultima Band Size 22	458-0022	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ul 1st Bi -2t4a G-Off .018	348-8411	EUDAMEDFDA UDI	Class IIa	Active
Arch D-Rect Braided Upr 021x025	201-0005	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Damon Q2 G-Off 022 -11/+2/0 Std Tq	491-8991	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Usm 15sgl Wdx -10tx18 L	515-0216	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Trimline Band Size 34	480-0034	EUDAMEDFDA UDI	Class IIa	Active
Ling.assy.twn.ufm.w/Sheath Band 018	367-0049	EUDAMED	Class IIa	Active
U4&5r Mtwin Bkt Flg 18 Rth Dbhk 0/-7/2	163-2019	EUDAMED	Class IIa	Active
L6r Llbt Bkt 2251 Andrews Hk 2/-30	138-0261	EUDAMED	Class IIa	Active
U7l Accent Mini Mbt .022 -14/0/+10	342-1375	EUDAMEDFDA UDI	Class IIa	Active
Purple Tma Baf .019x.025 Lo Sm Pk-5	211-4404	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 19x25lolgpk10	219-4312	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn/Hk Llcusp -7t +6a 22	304-1433	EUDAMED	Class IIa	Active
L6r Bkt 22 Andrews Hk Fcc 2/-30	138-0195	EUDAMEDFDA UDI	Class IIa	Active
U1l Titanium Orthos Bios .018 +22/+5/0	448-8119	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Damon Q2 022 -11/+2/0 Std Tq	491-8890	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp35d 019x025 Ll Pk10	227-1334	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 12	376-0012	EUDAMEDFDA UDI	Class IIa	Active
Zoo Master Pouch 3g 1/4 8oz Leopard	634-0001	EUDAMEDFDA UDI	Class IIa	Active
Respond Wire .0190 Diax14in Lgth Pk10	264-1119	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 2	653-0002	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2245 Roth Fcc Hk 0/-14/14	137-0061	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg 0t 022 Ndx Ul/Lr	342-6807	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 30	652-0030	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 40arch 19x25uplgpk10	219-5412	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF US 014 NiTi DIMPLE 10PK	227-3377	EUDAMEDFDA UDI	Class IIa	Active
L6r Ltbt Bkt 1845 Roth Mt Hk -1/-30/4	138-0186	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 30	330-0130	EUDAMEDFDA UDI	Class IIa	Active
L3l Twin Db/Mm 18 Andrews 5/-11	363-1058	EUDAMED	Class IIa	Active
18x25 SMARTARCH CUNITI DAMON UPPER PK10	210-1931	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 D/G Hk Roth G-Off 2bi -1/-22/4	339-1710	EUDAMEDFDA UDI	Class IIa	Active
U4 & 5r Sws Db/Om 22 D/G Hk Andrews G-Off Bi 2/-7/0	339-2522	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultimax Band Size 5	458-0105	EUDAMEDFDA UDI	Class IIa	Active
U6r Obt Bkt 1845 Andrews Mt Hk 5/-9/10	138-0056	EUDAMEDFDA UDI	Class IIa	Active
L3l Ti-Orthos .018 -6/+6/-4.5	448-6711	EUDAMEDFDA UDI	Class IIa	Active
L7r Alias Lingual .018 Hk 0/0/0	369-1090	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 22 Andrews Non G-Off 2/-22/0	339-0741	EUDAMEDFDA UDI	Class IIa	Active
U6l Db/Ul 22 Andrews Hk Fcc 5/-9/10	438-0153	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band Size 22	331-0122	EUDAMEDFDA UDI	Class IIa	Active
Mini-V Diam Ur Cusp Thn 0t +10a 022	351-6330	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Um 022x028 Nd Ppak 10pk	227-9037	EUDAMEDFDA UDI	Class IIa	Active
Damon Sl Align Se200 014 Dimple Ppak 10pk	227-1002	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.