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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 118 of 134

Device	Model / Reference	Registries	Class	Status
Prls 15 Ufm Combi B/T -10trq 18x51 Lt	195-0212	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Up Lge 0160x0160 Pk/10	210-0716	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 16	460-0016	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 32	479-0032	EUDAMEDFDA UDI	Class IIa	Active
Plier Ligature Mathieu Style	801-0064	EUDAMEDFDA UDI	Class I	Active
TRU-ARCH ALIGN XF US 018X025 NiTi DIMPLE 10PK	227-3340	EUDAMEDFDA UDI	Class IIa	Active
Alex Signature Assy-Lr 1bi -7t0a G-Off 018	354-3614	EUDAMEDFDA UDI	Class IIa	Active
Insignia Damon Q Single Patient Kit	728-0050	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .017x025lo Sm Pk10	211-0923	EUDAMEDFDA UDI	Class IIa	Active
DAMON ULTIMA CUNITI .014 x .0275 ARCHWIRE WITH ULTIMA HOOKS 5PK	227-0241	EUDAMEDFDA UDI	Class IIa	Active
L5r Damon3 Mx .022 -17/+2/0	494-4450	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF UM 016 NiTi ND 10PK	227-3369	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 014dia Ul Pk10	205-6401	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cis-Lr Lateral -4.5r -5t +4a .018	454-0630	EUDAMEDFDA UDI	Class IIa	Active
L4r Damon Q2 G-Off 022 -12/+4/0 Std Tq	491-8940	EUDAMEDFDA UDI	Class IIa	Active
Dq U3-3/L3&4 High Tq, U4&5 / L1&2&5 Std Tq	740-1511	EUDAMED	Class IIa	Active
Wire Round Spring .014 Diax14.0 Pk 50	266-1314	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LM 014 NiTi DIMPLE 10PK	227-3208	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 35	460-0035	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Niti Arch.017x.025upsm Pk10	219-3210	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultimax Band Size 16	460-0116	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultima Band Size 25	458-0025	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN XF US 19X25 NiTi ND 10PK	227-3346	EUDAMEDFDA UDI	Class IIa	Active
U4 & 5r Sws Db/Om 18 D/G Hk Roth G-Off Bi 0/-7/+2	338-1510	EUDAMEDFDA UDI	Class IIa	Active
L5l Damon Q2 022 -17/+4/0 Std Tq	491-8851	EUDAMEDFDA UDI	Class IIa	Active
5deg Sheath-R 036 W/Bhk Ea	088-4006	EUDAMEDFDA UDI	Class IIa	Active
Minidiamond Tw Llcus 1500433 -7t+6a18	350-0433	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Twin Bkt 18 Andrews Bhk 2/-7	163-1029	EUDAMEDFDA UDI	Class IIa	Active
Wire Ligature P/F .010dia Pk 1000	270-0010	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF US 016X016 Niti DIMPLE 10PK	227-3324	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Db/Ul 18 Roth Of/Gv 0/-17/4	428-0674	EUDAMED	Class IIa	Active
Orthos Cm Bkt-Ll Cus -4.5r -6t 6a 018	454-0711	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 40arch 17x25uplgpk10	219-5410	EUDAMEDFDA UDI	Class IIa	Active
L7l Bkt 18 Roth Mt Hk -1/-30/4	137-0200	EUDAMEDFDA UDI	Class IIa	Active
U3r Mtwnvs Db/Mtwin 18 Spec Bhk Lr 9/-2/4	318-1350	EUDAMED	Class IIa	Active
Orthos C/M-Lr 1st Bi -7t3a022	455-0814	EUDAMEDFDA UDI	Class IIa	Active
Orthos Lsm 6dg -10t B/T Wdx Lr .022	512-2119	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 6	488-0006	EUDAMEDFDA UDI	Class IIa	Active
Arch Rev.curve Niti Lo.019 X.025 Pk10	217-1925	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE CUNITI .016 x .016 MED PK10	204-2122	EUDAMEDFDA UDI	Class IIa	Active
U3l Symetri Clear Mclaughlin, Bennett & Trevisi .022 0/8/0	419-1311	EUDAMEDFDA UDI	Class IIa	Active
Mini Diam Mtwn Ulcus W/Hk+7t +10a 018	350-1381	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -27t 018 Ndx Lr	340-6227	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultima Band Size 36	459-0036	EUDAMEDFDA UDI	Class IIa	Active
Tma Broad Arch Round.016 Lo Lge Pk/10	211-0311	EUDAMEDFDA UDI	Class IIa	Active
L1&2r Mtwn Rec Db/Mtwn 18 And/Rth 0/-1 Bhk	328-1020	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 UM 016 NiTi DIMPLE 10PK	227-3153	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 21x25 Nd Ppak10pk	227-9008	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 2245 Andrews Mt Hk 5/-9/10	138-0033	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Q2 022 +7/+5/0 Std Tq	491-8881	EUDAMEDFDA UDI	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.