Is this your brand? Sign in to claim ownership.

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 121 of 134

Device	Model / Reference	Registries	Class	Status
U3l Damon Q .022 +11/+5/0 Hi Tq Hk	491-7685	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 18	486-0018	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Urcent +14t +5a 022	304-0170	EUDAMED	Class IIa	Active
U2r Minitwin Db/Mtwin 18 Andrews 9/3 Bhk	328-1220	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 13	651-0013	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Ndx -22tx18 Ll	515-0122	EUDAMEDFDA UDI	Class IIa	Active
U6r Cbt Db/Ul 2245 Andr Hk Cap 5/-9/10	438-0037	EUDAMED	Class IIa	Active
3/16" Pads For Band Removing Pliers	866-2061	EUDAMEDFDA UDI	Class I	Active
U3r Attract Db/Am 22 Suptq Bhk 9/3/4	364-7003	EUDAMED	Class IIa	Active
Spring Coil Space Wound Pkg 008 X 030	221-0830	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Std High Retention Band Size 25	651-0125	EUDAMEDFDA UDI	Class IIa	Active
Power Chain White Closed Space	639-0048	EUDAMEDFDA UDI	Class IIa	Active
L6l Db/Ul 22 Roth Ss Mt Hk -1/-30/4	438-0110	EUDAMEDFDA UDI	Class IIa	Active
U6l Cbt Db/Ul 2245 Roth Mt Hk 0/-14/14	438-0148	EUDAMEDFDA UDI	Class IIa	Active
Unidose Ortho Solo	740-0269	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH CUNITI NON-DIMP35D 017x017LL PK10	211-9211	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Clear 2 .022 +7/+5/0 Std Tq Hk	497-7581	EUDAMEDFDA UDI	Class IIa	Active
Opt Mini-D Wick Ul Cuspid -3t+10a 022	351-3311	EUDAMEDFDA UDI	Class IIa	Active
Cast 5deg Lfm Conv B/T -22trq 022 Rt	188-0203	EUDAMEDFDA UDI	Class IIa	Active
Advansync 2 Kit	600-4200	EUDAMEDFDA UDI	Class IIa	Active
Ling.hrt.assy.upr Lat Lt .022	368-5012	EUDAMED	Class IIa	Active
Vectortas Double Delta 10mm 150g Spring Pk6	601-0037	EUDAMEDFDA UDI	Class IIa	Active
U7r Db/Ul 22 Andrews Mt Hk 0/-9/10	438-0076	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Trimline Band Size 14	488-0014	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ul Wdx-10t X 018	512-2110	EUDAMEDFDA UDI	Class IIa	Active
U2l Minitwin Db/Mtwin 22 Suptq 9/10	329-0241	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Minitwin Rec Bkt Flng 22 Andrews Mbhk 0/-7	164-2030	EUDAMED	Class IIa	Active
Color Master Pack - 2d 3/16 Rabbit	636-0114	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Ll 2 Bi-17t G-Offset .018	348-6917	EUDAMEDFDA UDI	Class IIa	Active
Triumph Wax Mixing Pad	TRIUMPH WAX MIXING PAD	EUDAMEDFDA UDI	Class I	Active
Mosquito Hemostat	801-0037	EUDAMEDFDA UDI	Class I	Active
Upper Right Second Molar Washbon Band Size 21	371-0021	EUDAMEDFDA UDI	Class IIa	Active
L3l Minitwin Db/Mtwin 18 Damon Rx 5/0 Bhk	328-1431	EUDAMEDFDA UDI	Class IIa	Active
Lingual Cleat --Molar--ormco--	613-0010	EUDAMEDFDA UDI	Class IIa	Active
Spark 10 – Combo Single Arch Symetri	728-3011-AC-S	EUDAMED	Class IIa	Active
U2l Attract Db/Am 18 Suptq 9/10	363-7019	EUDAMED	Class IIa	Active
Mini-Diamnd Urcus 1510330 Whk0t+10a22	351-1330	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Rec Db/Ul 22 Roth Bhk 0/-17/4	429-1610	EUDAMEDFDA UDI	Class IIa	Active
L1&2r Twin Db/Mm 22 Set I/Roth 2/-1	364-1106	EUDAMED	Class IIa	Active
Tru-Arch Ss Us 021x025 Nd Ppak 10pk	227-9052	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 18	479-0018	EUDAMEDFDA UDI	Class IIa	Active
ORTHOSCM BKT-UR LAT -4.5R +9T 9a .022 W/HK	455-1210	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Tw Ulcen 1510131 +14t+5a22	351-0131	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M - Ur Lat +9t 9a .022	455-0212	EUDAMEDFDA UDI	Class IIa	Active
U1l Attract Db/Am 22 Roth 5/12	364-7018	EUDAMED	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 20	651-0020	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon3 Mx .022 -12/+2/0	494-4441	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Niti Arch.016x.022uplg Pk10	219-3408	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 016 Nd Bulk 50pk	227-9069	EUDAMEDFDA UDI	Class IIa	Active
Pref.ling.arch Ni-Ti Up.018 Sz3 Pk/10	205-0022	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.