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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 23 of 134

Device	Model / Reference	Registries	Class	Status
Crown W/Cutout-Advansync 2 U6l Size 5 Pk5	600-4305	EUDAMEDFDA UDI	Class IIa	Active
Power O Short Stick .120 Red Pack1000	640-1245	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Trimline Band Size 10	480-0010	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 020 Nd Bulk 50pk	227-9071	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 19	486-0019	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 20	652-0020	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Mtw Llibi 1700211 -11t 0awhk22	342-1318	EUDAMEDFDA UDI	Class IIa	Active
Crown W/Cutout-Advansync 2 L6r Size 5 Pk5	600-4335	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl 2nd Ndx -10tx22 Ur	514-0111	EUDAMEDFDA UDI	Class IIa	Active
Twn Bkt Wedge Nar Upr Cus&Bic-7trq022	170-0107	EUDAMEDFDA UDI	Class IIa	Active
U7l Bkt 22 Roth Mt Hk 0/-14/14	137-0181	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0032	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Um 014 Nd Ppak 10pk	227-9038	EUDAMEDFDA UDI	Class IIa	Active
Orth Accent Lfm 0 Dbl-10x.018 Lt	340-1236	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Urcuspid 0t +10a 18	303-0330	EUDAMED	Class IIa	Active
Arch Alexand Tma Lo Sml 019x025 Pk/10	207-0061	EUDAMEDFDA UDI	Class IIa	Active
Prls 10 Ufm Combi B/T -10trq 18x51 Lt	195-0204	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Customband-Bracket1-Lingual3	BB1L3	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Bkt 22 Roth Mbhk 0/-7/2	164-1106	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Clear .022 +7/+5/0 Std Tq Hk	497-7481	EUDAMEDFDA UDI	Class IIa	Active
F/Bow Britegear Minshort#4 044 White	200-0744	EUDAMEDFDA UDI	Class IIa	Active
U6l Tbt Bkt 1851 Roth Mt Hk 0/-14/14	137-0092	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Trimline Band Size 5	435-0005	EUDAMEDFDA UDI	Class IIa	Active
L3l Mtwn Vs Db/Mtwn 18 Roth Dbhk 7/-11/2	318-1411	EUDAMED	Class IIa	Active
U6r Bkt 22 Andrews Hk Fcc 5/-9/10	138-0003	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 20	653-0120	EUDAMEDFDA UDI	Class IIa	Active
L3r Damon Ultima 22 Retrocline Tq	333-4310	EUDAMEDFDA UDI	Class IIa	Active
L5l Attract Db/Am 18 Andrews Bhk 2/-22	363-7031	EUDAMED	Class IIa	Active
5deg Sheath-R 036 No Hk Ea	088-4008	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 19	652-0119	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 28	372-0028	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 15	486-0015	EUDAMEDFDA UDI	Class IIa	Active
Insignia Ice 5 - 5 Kit	728-0021	EUDAMEDFDA UDI	Class IIa	Active
Cast 5deg Lfm Conv B/T -22trq 018 Lt	187-0204	EUDAMEDFDA UDI	Class IIa	Active
L7r Db/Ul 22 Spec Mt Hk 2/-10	438-0033	EUDAMEDFDA UDI	Class IIa	Active
U7r Db/Ul 22 Roth Spec Mt Hk 2-Slot 0/-14/14	438-0088	EUDAMED	Class IIa	Active
Ni-Ti Broad Arch Lolge 0160 0220 Pk10	211-0512	EUDAMEDFDA UDI	Class IIa	Active
Crimpable Ball Hooks - 50 Pack	704-9000	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamnd Tw Lrcus 1510422 0t +6a22	351-0422	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 4	374-0004	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Washbon Band Size 1	372-0001	EUDAMEDFDA UDI	Class IIa	Active
U2l Damon Q2 022 -5/+9/0 Low Tq	491-8873	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 8	479-0008	EUDAMEDFDA UDI	Class IIa	Active
DAMON CUNITI .014 x .025 ARCHWIRE WITH ULTIMA HOOKS 5PK	227-0141	EUDAMED	Class IIa	Active
Tru-Arch Ss 4keyloop Us 36mm 019x025 Nd Bulk 10pk	227-5039	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Us 018x025 Nd Ppak 10pk	227-9049	EUDAMEDFDA UDI	Class IIa	Active
Ss Broad Arch Round.0180 Up Lge Pk/20	210-0128	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Sst Arch 017x025 Lolg Pk10	219-1310	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Tw Ulcen 1500131 +14t+5a18	350-0131	EUDAMEDFDA UDI	Class IIa	Active
L4l Damon Q2 G-Off 022 -12/+4/0 Std Tq	491-8941	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.