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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 19 of 134

Device	Model / Reference	Registries	Class	Status
Upper Right Second Molar Std High Retention Band Size 11	651-0011	EUDAMEDFDA UDI	Class IIa	Active
U2r Minitwin Db/Mtwin 22 Suptq 9/10	329-0240	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Sst Lo Sml 016x022 Pk/10	207-0035	EUDAMEDFDA UDI	Class IIa	Active
L1l Damon Ultima 22 Retrocline Tq	333-3110	EUDAMEDFDA UDI	Class IIa	Active
Minidiamond Tw Urlat 1500210 0t +8a18	350-0210	EUDAMEDFDA UDI	Class IIa	Active
L3l Sws Db/Om 18 Hk Roth Cuspid 7/-11/2	338-1411	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Assembly Ul Lat 14t9a.018	348-6219	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Ultimax Band Size 11	459-0111	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Second Bicuspid Band Size 15	330-0115	EUDAMEDFDA UDI	Class IIa	Active
Arch Tma Rect Man .021 X.025 Pk 10	202-0017	EUDAMEDFDA UDI	Class IIa	Active
U3r Sws Db/Om 22 Hk Andrews Cuspid 11/-7	339-1320	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp35d 016dia Ll Pk10	205-6312	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Lr 2nd Bi -17t 0a 18	303-0722	EUDAMED	Class IIa	Active
U5r Twin Db/Ul 22 T2 Pa -1/-7/4	464-1002	EUDAMED	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 23	654-0023	EUDAMEDFDA UDI	Class IIa	Active
L1l Damon Q2 022 -3/+2/0 Std Tq	491-8811	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 LM 017X025 NiTi DIMPLE BULK 10PK	227-3503	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ll Central -10t2a .022	455-0617	EUDAMEDFDA UDI	Class IIa	Active
Spark 35 R2 - Reorder	728-3236-R	EUDAMED	Class IIa	Active
Orthoscm Sst Arch .020 Dia Uplg Pk10	219-1592	EUDAMEDFDA UDI	Class IIa	Active
L6l Bkt 22 Spec Mt Hk Bal 0/-10	137-0231	EUDAMEDFDA UDI	Class IIa	Active
U2l Minitwin Db/Mtwin 18 Suptq 9/10	328-0241	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 16	654-0016	EUDAMEDFDA UDI	Class IIa	Active
Orthos C/M-Ll 2nd Bi G-Off/Hk -9t3a018	454-1911	EUDAMEDFDA UDI	Class IIa	Active
Ni-Ti Broad Arch Uplge 0170 0250 Pk10	210-0513	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 32	653-0132	EUDAMEDFDA UDI	Class IIa	Active
U2r Titanium Orthos Bios .022 +14/+9/-4.5	449-8218	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Twin Bkt 22 Roth Nhk 0/-7/2	164-1110	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Washbon Band Size 25	375-0025	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 18 Roth G-Off 2bi -1/-22/4	338-0711	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Sst Arch 016x022 Losm Pk10	219-1108	EUDAMEDFDA UDI	Class IIa	Active
Mini-X Twn Bkt U/Lbicusp 0trq 022	151-0506	EUDAMED	Class IIa	Active
DAMON NiTi 38mm PRE-TRQ 20 DEG 019 X 025 PK5	227-0383	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Tma Arch 017x025 Losm Pk10	219-2110	EUDAMEDFDA UDI	Class IIa	Active
U1r Twin Db/Mm 18 Set Iv 3/14	363-1027	EUDAMED	Class IIa	Active
Accent Bt 5sgl -27x22 F/Sm Lr	342-4131	EUDAMEDFDA UDI	Class IIa	Active
U3r Damon Clear 2 .022 +7/+5/0 Std Tq	497-6580	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 016 Nd Ppak 10pk	227-9021	EUDAMEDFDA UDI	Class IIa	Active
L1l Damon Q .022 -3/+2/0 Std Tq	491-6411	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Bkt 22 Andrews Bhk 2/-7	164-1130	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 UM 017X025 NiTi ND 10PK	227-3138	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp35d 018dia Ul W/Stops Pk10	227-1370	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 20	371-0020	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultimax Band Size 9	457-0109	EUDAMEDFDA UDI	Class IIa	Active
L5r Damon Q2 022 -17/+4/0 Std Tq	491-8850	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Bkt Flng 22 Andrews Nhk 0/-22	164-2021	EUDAMEDFDA UDI	Class IIa	Active
L6l Bkt 22 Rth Ss Mt Hk Hipl -1/-30/4	137-0229	EUDAMEDFDA UDI	Class IIa	Active
Damon Ultima Archwire Tma 10pk 18x275	227-1118	EUDAMEDFDA UDI	Class IIa	Active
Power Chain -gen Ii-Clear- Wide Space	639-0019	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower First Bicuspid Band Size 5	332-0105	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.