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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 15 of 134

Device	Model / Reference	Registries	Class	Status
Orthosc/M-Ur Cuspid -3 T 10a .022	455-0310	EUDAMEDFDA UDI	Class IIa	Active
U6r Sl B/T Damon .022 Flg -18/0/+12	513-1244	EUDAMED	Class IIa	Active
L4r Twin Db/Ul 22 Roth Hk -1/-17/4	464-1058	EUDAMED	Class IIa	Active
Upper Left Second Molar Trimline Band Size 7	487-0007	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF US 012 NiTi DIMPLE 10PK	227-3393	EUDAMEDFDA UDI	Class IIa	Active
L7l Db/Ul 18 Spec Mt Hk 2/-10	437-0121	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 Roth Non G-Off -1/-22/4	339-0730	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Um 021x025 Nd Ppak 10pk	227-9036	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP27D 016x025UL PK10	210-9202	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Tma 017 X 025 Upsm Pk10	219-2210	EUDAMEDFDA UDI	Class IIa	Active
L1l Damon Q .022 -11/+2/0 Lo Tq	491-6415	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 32	489-0032	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 27	376-0027	EUDAMEDFDA UDI	Class IIa	Active
Arch Rev.curve Niti Up .016 X.025 Pk10	216-1625	EUDAMEDFDA UDI	Class IIa	Active
L7r Bkt 22 Andrews T3 Pa -2/-31/6	138-0281	EUDAMEDFDA UDI	Class IIa	Active
U2l Titanium Orthos2 D-G Hk .018 +9/+9/-4.5	448-9211	EUDAMEDFDA UDI	Class IIa	Active
Stop Wound Spring Tma .0090x.060 Pk3	222-0901	EUDAMEDFDA UDI	Class IIa	Active
Orthos Lsm 6dg -10t B/T Wdx Ll .022	342-5057	EUDAMEDFDA UDI	Class IIa	Active
Master Pouch 15 6g 1/2 Lt Lion	635-0062	EUDAMEDFDA UDI	Class IIa	Active
U2l Damon Clear .022 +6/+9/0 Std Tq	497-6471	EUDAMEDFDA UDI	Class IIa	Active
Ling.assy.twn.w/Hk U/R Molar Band 018	367-1906	EUDAMED	Class IIa	Active
Spark Advanced - Refinement	728-3032	EUDAMEDFDA UDI	Class IIa	Active
Peerless Mini-Term B/T-10t X 22 Ul	342-0013	EUDAMEDFDA UDI	Class IIa	Active
Tma Broad Arch Up Sml 0210 0250 Pk/10	210-0405	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 21	378-0021	EUDAMEDFDA UDI	Class IIa	Active
Crimpable Stop 2mm .030 I.d. X .041 O.d. Pk40	623-0263	EUDAMEDFDA UDI	Class IIa	Active
Twnbkt Dmd Wid Cent+14trq +5ang 018lt	111-0424	EUDAMED	Class IIa	Active
Copper Niti 27 Baf .019x.025l/S Pk10	211-0905	EUDAMEDFDA UDI	Class IIa	Active
Mini Diam Ntwn Thk Ullat +7t +8a 022	351-0271	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0026	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 24	457-0024	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ll 1st Bi /hk -7t3a022	455-1815	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 23	459-0123	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Align Se200 Um 016 Nd Ppak 10pk	227-3154	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Cuniti 35arch 19x25upsmpk10	219-4212	EUDAMEDFDA UDI	Class IIa	Active
Arch Ling Sst 18x25 Pk 10	206-0008	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 26	489-0026	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 3	654-0103	EUDAMEDFDA UDI	Class IIa	Active
U1r Minitwin Db/Mtwin 22 Andrews 5/7	329-0120	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm B/T Lfm Odbl -10x022 Rt	342-0046	EUDAMEDFDA UDI	Class IIa	Active
U4 & 5l Sws Db/Om 18 Roth Non G-Off 0/-7/2	338-0531	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 97	372-0097	EUDAMEDFDA UDI	Class IIa	Active
Diamond Wtw Ulcen 1110424 +14t+5a 018	347-1121	EUDAMED	Class IIa	Active
Copper Niti 35 Baf 17x25 Up Lg Pk10 W/Stops	299-0033	EUDAMEDFDA UDI	Class IIa	Active
U2r Attract Db/Am 18 Suptq 9/10	363-7009	EUDAMED	Class IIa	Active
Upper Right First Molar Washbon Band Size 29	377-0029	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Bkt 1845 Andrews Mt Hk 5/-9/10	138-0020	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Ur Cusp/Hk +7t 10a .018	348-7318	EUDAMEDFDA UDI	Class IIa	Active
L4&5l Minitwin Vs Db/Ul 22 Bhk Bi-Di 0/0	493-1621	EUDAMED	Class IIa	Active
Lower Right First Molar Washbon Band Size 25	373-0025	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.