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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 123 of 134

Device	Model / Reference	Registries	Class	Status
U2r Attract Db/Am 18 Roth 9/8	363-7010	EUDAMED	Class IIa	Active
Orthosc/M-Ur Cuspid W/Hook -3t10a.018	454-1310	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE TMA .0175 x .0175 SM PK10	204-2211	EUDAMEDFDA UDI	Class IIa	Active
Arch P/F Edg.rect.lo.0180 X.0220 Pk10	209-1822	EUDAMEDFDA UDI	Class IIa	Active
L2r Ti-Orthos .022 -5/+4/-4.5	449-6620	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 014dia Ll Pk10	205-6301	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Tma Upper 016x022 Pk/10	207-0045	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 17	488-0017	EUDAMEDFDA UDI	Class IIa	Active
U3r Sws Db/Om 18 Hk Super Torque Cuspid 9/3/4	338-1340	EUDAMEDFDA UDI	Class IIa	Active
L5r Attract Db/Am 18 Andrews Bhk 2/-22	363-7055	EUDAMED	Class IIa	Active
Upper Right Second Molar Trimline Band Size 1	486-0001	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamond Tw Urcen 1500120+7t+5a18	350-0120	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Black Open Space	639-0032	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ll 1st Bi/Hk -7t3a018	454-1815	EUDAMEDFDA UDI	Class IIa	Active
Mini-V Diam Lr Cusp W/Hk -7t +6a 018	350-7432	EUDAMEDFDA UDI	Class IIa	Active
5-5 U/L Damon Q2 Single Patient Kit Std Tq	740-1410	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Washbon Band Size 26	375-0026	EUDAMEDFDA UDI	Class IIa	Active
Compression Spring Niti 010x030 Pk 3	221-5510	EUDAMEDFDA UDI	Class IIa	Active
Optical Pliers	803-0204	EUDAMEDFDA UDI	Class I	Active
Zoo Master Pack 2c 3/16 Med Otter	630-0020	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 30	489-0030	EUDAMEDFDA UDI	Class IIa	Active
Arch P/F Edg.rect.lo.0180 X.0250 Pk10	209-1825	EUDAMEDFDA UDI	Class IIa	Active
L7r Bkt Lbbt 22 Bioprog Mt Hk 0/-27/2	138-0291	EUDAMEDFDA UDI	Class IIa	Active
U2r Symetri Clear Mclaughlin, Bennett & Trevisi .022 +10/8/0	419-1210	EUDAMEDFDA UDI	Class IIa	Active
L5l Twin Db/Ul 18 Andrews 2/-22	463-1022	EUDAMED	Class IIa	Active
Power Chain Maroon Closed Space	639-0065	EUDAMEDFDA UDI	Class IIa	Active
U1l Minitwin Db/Mtwin 22 Suptq 5/17	329-0141	EUDAMEDFDA UDI	Class IIa	Active
L5 Univ Symetri Clear Mclaughlin, Bennett & Trevisi .018 -17/0/0	418-1710	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -27t 018 Wdx Ll	340-5327	EUDAMEDFDA UDI	Class IIa	Active
U3r Attract Db/Am 22 Andrews 11/-7	364-7000	EUDAMED	Class IIa	Active
Alex Signature Mesh W/Hook-Lr Lateral -5t +6a .018	354-4062	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Wdx-20tx018	512-2104	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Bkt Flng 18 And 0/-22	163-2004	EUDAMED	Class IIa	Active
ORTHOS CM CuNiTi DIMP ARCH 27DEG .018 LOLG PK10	219-7218	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultimax Band Size 6	460-0106	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP27D 016x022US PK10	210-9103	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 11	653-0011	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 26	378-0026	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Trimline Band Size 26	487-0026	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band Size 15	331-0115	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 29	652-0129	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK	227-3135	EUDAMEDFDA UDI	Class IIa	Active
U1r Sws Db/Om 18 Andrews Central 5/7	338-0120	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultima Band Size 29	458-0029	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Ll 2nd Bi -17t 0a 18	303-0723	EUDAMED	Class IIa	Active
U4&5l Minitwin Rec Db/Ul 18 Andrews Bhk 0/-7	428-1521	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Niti Arch.016 Dia Lolg Pk10	219-3303	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamnd Tw Ullat 1510231+14t+8a22	351-0231	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 11	330-0111	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Washbon Band Size 19	373-0019	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.