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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 130 of 134

Device	Model / Reference	Registries	Class	Status
ORTHOS CM CUNITI 35ARCH 17x17 LOSM PK/10	219-4109	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Urcent +14t +5a 22	304-0130	EUDAMED	Class IIa	Active
U1l Minitwin Vs Db/Mtwin 18 Roth 5/12	318-0111	EUDAMED	Class IIa	Active
U3l Sws Db/Om 22 Roth Cuspid 13/-2/4	339-0311	EUDAMEDFDA UDI	Class IIa	Active
Arch Tma Rev.curve Lwr 016x022 Pk/10	216-0003	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Odbl Lfm -10x18x18 Lt	521-0236	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 16di Lolgpk10	219-4303	EUDAMEDFDA UDI	Class IIa	Active
L5l Minitwin Rec Db/Ul 22 Andrews Bhk 0/-22	429-1721	EUDAMEDFDA UDI	Class IIa	Active
Prls 2ndmol B/T 12deg -27t 022 Ndx Lr	517-2107	EUDAMEDFDA UDI	Class IIa	Active
Damon Clear Debonding Plier	866-4019	EUDAMEDFDA UDI	Class I	Active
TRU-ARCH CUNITI NON-DIMP27D 017x025UL PK10	210-9204	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 LM 018X018 NiTi DIMPLE 10PK	227-3676	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Lo Sml 0160x0220 Pk/10	211-0701	EUDAMEDFDA UDI	Class IIa	Active
Niti Open Coil 010x030x15 In.	704-6052	EUDAMEDFDA UDI	Class IIa	Active
U7r Ubbt Db/Ul 18 Bioprog Mt Hk 0/-10/12	437-0051	EUDAMED	Class IIa	Active
Tru-Arch Ss Posted 30mm Lm 020 Nd Bulk 10pk	227-7024	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 29	653-0029	EUDAMEDFDA UDI	Class IIa	Active
Damon Ss Posted 28mm 16x25 Nd Bulk10pk	227-1030	EUDAMEDFDA UDI	Class IIa	Active
Tma Wire Rect.0175x.0175 14inlg Pk 10	266-0012	EUDAMEDFDA UDI	Class IIa	Active
Spark Junior (phase 1) - Refinement	728-3220-S	EUDAMED	Class IIa	Active
Honeydew Tma Baf.019x.025 Lo Sm Pk-5	211-5404	EUDAMEDFDA UDI	Class IIa	Active
L6r Bkt 18 Roth Ss Mt Hk -1/-30/4	138-0134	EUDAMEDFDA UDI	Class IIa	Active
Min Dmd Wick L2bicusp W/Hk-17t 0a 018	350-4725	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Ll 2nd Bi -17t 0a 22	304-0723	EUDAMED	Class IIa	Active
Peerless 2ndmol 6deg Lr Wdx-20tx022	513-2103	EUDAMEDFDA UDI	Class IIa	Active
Peerless Tpl 15ufm-10x22 0x21x45 Hklt	173-0421	EUDAMEDFDA UDI	Class IIa	Active
Mini-T Twn Bkt L01bic -11 0 022	151-6615	EUDAMED	Class IIa	Active
U6r Obt Bkt 1845 Roth Mt Hk 0/-14/14	138-0062	EUDAMEDFDA UDI	Class IIa	Active
U2l Minitwin Vs Db/Mtwin 22 Roth 9/8	319-0211	EUDAMED	Class IIa	Active
Peerless 2ndmol 6deg Ur/Ll Ndx Otx018	512-2202	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Std High Retention Band Size 21	651-0121	EUDAMEDFDA UDI	Class IIa	Active
Minidiamd Tw Ullat Thk1500251+7t+8a18	350-0251	EUDAMEDFDA UDI	Class IIa	Active
U3l Attract Db/Am 22 Damon Rx Bhk 6/0	364-7031	EUDAMED	Class IIa	Active
L2r Damon Ultima 22 -1/4/0 Neutral Tq	333-4200	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Bkt 2245 And T2 Hk Cp 2/-14/14	137-0045	EUDAMEDFDA UDI	Class IIa	Active
U7r Db/Ul 18 Andrews Mt Hk 0/-9/10	437-0043	EUDAMEDFDA UDI	Class IIa	Active
U6l Udbt Bkt 22 Rt Mt Hk Nt 0/-14/14	137-0293	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Sst Lo Sml 017x025 Pk/10	207-0040	EUDAMEDFDA UDI	Class IIa	Active
Min Dmd Wick L1bicusp W/Hk-11t 0a 018	350-4615	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 M/G Hk And G-Off Bi 2/-22	339-2720	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -20t 018 Wdx Ll	340-5317	EUDAMEDFDA UDI	Class IIa	Active
U3r Twin Db/Mm 18 Roth Sr 13/-2/4	363-1004	EUDAMED	Class IIa	Active
Mini2000 Dmd Twn Ulcuspid 0t +10a 22	304-0331	EUDAMED	Class IIa	Active
U4, 5l Damon Ultima 22 Procline Tq	333-2420	EUDAMEDFDA UDI	Class IIa	Active
L5r Damon Q2 022 -17/+4/0 Std Tq - Hook	491-9850	EUDAMEDFDA UDI	Class IIa	Active
Tma Rev.curve/Loops 019x025 36mm Pk/5	215-0044	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Posted 42mm Um 019x025 Nd Bulk 10pk	227-7053	EUDAMEDFDA UDI	Class IIa	Active
Mini Diam Mtwn Ur Cent +14t +5a 018	350-0170	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Twin Db/Ul 22 Roth Mbhk 0/-7/2	464-1096	EUDAMED	Class IIa	Active
Lower Right Second Molar Washbon Band Size 4	375-0004	EUDAMEDFDA UDI	Class IIa	Active

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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.