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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 127 of 134

Device	Model / Reference	Registries	Class	Status
Accent B/T 5sgl 2nd Ndx -10tx22 Ul	515-0111	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 20	330-0120	EUDAMEDFDA UDI	Class IIa	Active
L6l Accent Mini Damon W/T-Hook.022-28/+2/+2	513-0165	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 13	460-0013	EUDAMEDFDA UDI	Class IIa	Active
L5l Attract Db/Am 22 Andrews 2/-22	364-7036	EUDAMED	Class IIa	Active
Ormesh Mtw L2bi 1700213 -17t 0a 022	342-1515	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 21	479-0021	EUDAMEDFDA UDI	Class IIa	Active
Pref.ling.arch 35 Cuniti 017x025 Lw Sz3 Pk10	205-0087	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 Roth G-Off 2bi -1/-22/4	339-0710	EUDAMEDFDA UDI	Class IIa	Active
L4l Minitwin Rec Db/Ul 18 Roth Bhk 0/-17/4	428-1611	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 28	371-0028	EUDAMEDFDA UDI	Class IIa	Active
U6l Tgbt Bkt 1845 Roth Mt Hk 0/-14/14	137-0096	EUDAMEDFDA UDI	Class IIa	Active
U6r Udbt Db/Ul 22 Roth Mthk No Hgtube 0/-14/14	438-0074	EUDAMEDFDA UDI	Class IIa	Active
U3l Sws Db/Om 22 Hk Super Torque Cuspid 9/3/4	339-1341	EUDAMEDFDA UDI	Class IIa	Active
UP/LO4&5 UNIV STb STRAIGHTWIRE .018 0/0/0	369-2403	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 27	653-0127	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -10t 022 Wdx Ul	342-5147	EUDAMEDFDA UDI	Class IIa	Active
Pref.ling.arch Ni-Ti Lo.018 Sz1 Pk/10	205-0032	EUDAMEDFDA UDI	Class IIa	Active
Peerlss Upper B/T -10x018x045 Ging Rt	194-0106	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Trimline Band Size 11	487-0011	EUDAMEDFDA UDI	Class IIa	Active
Wire Tma Round .032 Dia.x 14 In. Pk10	266-0004	EUDAMEDFDA UDI	Class IIa	Active
Angulated Bracket Remover	803-0104	EUDAMEDFDA UDI	Class I	Active
Universal Lower Second Bicuspid Band Size 17	330-0117	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp27d 016dia Ls Pk10	205-6102	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LS 014 NiTi ND 10PK	227-3217	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultima Band Size 25	460-0025	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 24	371-0024	EUDAMEDFDA UDI	Class IIa	Active
Power O Short Stick .120 White Pack1000	640-1248	EUDAMEDFDA UDI	Class IIa	Active
Power Chain Silver Open Space	639-0054	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Std High Retention Band Size 23	654-0123	EUDAMEDFDA UDI	Class IIa	Active
U3l Minitwin Db/Mtwin 22 Roth Bhk Lr 13/-2/4	329-1311	EUDAMEDFDA UDI	Class IIa	Active
Bondable Lingual Retainer Cuspid 3	204-0013	EUDAMEDFDA UDI	Class IIa	Active
Tma Broad Arch Round.016 Up Lge Pk/10	210-0311	EUDAMEDFDA UDI	Class IIa	Active
U3r Damon Clear .022 +11/+5/0 Super Tq Hk	497-7484	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 17	489-0017	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 18 Roth Non G-Off -1/-22/+4	338-0731	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 35 Baf .016x022lo Sm Pk10	211-0922	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultimax Band Size 14	458-0114	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0019	EUDAMEDFDA UDI	Class IIa	Active
Arch P/F Edg.rect.lo.0190 X.0250 Pk10	209-1925	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ll Wdx-27tx018	512-2106	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 15	654-0015	EUDAMEDFDA UDI	Class IIa	Active
L6l Dbt Bkt 22 Andrews Hk Fcc 2/-30	137-0243	EUDAMED	Class IIa	Active
U5l Ti-Orthos G-Off .018 -8/+4/0	448-6511	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 11	654-0011	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band With Lug Size 19	331-0319	EUDAMEDFDA UDI	Class IIa	Active
STb STRAIGHTWIRE EXTRACTION UP/LO 7x7 .018 SPK	740-0421	EUDAMEDFDA UDI	Class IIa	Active
L4l Minitwin Db/Ul 18 Roth Of/Gv 0/-17/4	428-0673	EUDAMED	Class IIa	Active
U6r Alias Lingual .018 +10/0/+05	369-0060	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Ndx -27tx18 Ll	515-0132	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

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.