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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 21 of 134

Device	Model / Reference	Registries	Class	Status
L3l Twin Db/Mm 18 Andrews Dbhk 5/-11	363-1061	EUDAMED	Class IIa	Active
Upper Right Ultima Band Size 7	457-0007	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Washbon Band Size 21	375-0021	EUDAMEDFDA UDI	Class IIa	Active
U3l Sws Db/Om 22 Andrews Cuspid 11/-7	339-0321	EUDAMEDFDA UDI	Class IIa	Active
L4r Sws Db/Om 18 D/G Hk Roth G-Off 1bi -1/-17/4	338-1610	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Attract Db/Am 22 Andrews 2/-7/0	364-7088	EUDAMED	Class IIa	Active
Cotton Tweezer	849-0000	EUDAMEDFDA UDI	Class I	Active
Twn Bkt Mini Med Lwrbic -17 Trq 022	170-0215	EUDAMED	Class IIa	Active
Damon Ss Posted 40mm 16x25 Nd Bulk10pk	227-1042	EUDAMEDFDA UDI	Class IIa	Active
L3r Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/3/2	418-1410	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexand Tma Lo Lrg 019x025 Pk/10	207-0062	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Rec Db/Ul 22 Andrews Bhk 0/-17	429-1620	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Mtwin U Bic 1700208 -7t 0a 018	340-1404	EUDAMED	Class IIa	Active
L4r Twin Db/Ul 22 Andrews T2 Pa 5/-17/4	464-1063	EUDAMED	Class IIa	Active
Ss Broad Arch Round.0160 Lo Sml Pk/20	211-0026	EUDAMEDFDA UDI	Class IIa	Active
Cast 5deg Lfm Conv B/T -22trq 018 Rt	188-0204	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Trimline Band Size 31	479-0031	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN XF LM 017X025 NiTi ND 10PK	227-3231	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Clear 2 .022 +7/+5/0 Std Tq	497-6581	EUDAMEDFDA UDI	Class IIa	Active
5deg Sheath-L 036 No Hk Ea	088-4009	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond U/L 5-5 Std Tq With Hk(.022)	740-1517	EUDAMED	Class IIa	Active
Upper Right First Molar Trimline Band Size 19	479-0019	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Db/Ul 22 Roth 0/-7/2	464-1083	EUDAMED	Class IIa	Active
L1l Damon Q2 022 -11/+2/0 Low Tq	491-8815	EUDAMEDFDA UDI	Class IIa	Active
Ni-Ti Broad Arch Uplge 0175 0175 Pk10	210-0511	EUDAMEDFDA UDI	Class IIa	Active
Insignia Kit	728-0000	EUDAMEDFDA UDI	Class IIa	Active
U4 & 5r Sws Db/Om 22 Roth Non G-Off 0/-7/2	339-0530	EUDAMEDFDA UDI	Class IIa	Active
Prls 10 Ufm Combi B/T -10trq 18x51 Rt	196-0204	EUDAMEDFDA UDI	Class IIa	Active
L3l Damon Q2 022 +7/+5/0 Std Tq - Hook	491-9831	EUDAMEDFDA UDI	Class IIa	Active
Mini-Dmd Ul Cusp W/Mes.hk +7t+10a.018	350-1361	EUDAMEDFDA UDI	Class IIa	Active
L6r Llbt Bkt 1845 Andrews Hk 2/-30	138-0174	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Washbon Band Size 12	371-0012	EUDAMEDFDA UDI	Class IIa	Active
D3mx Drop-In Hook Pk30	242-0012	EUDAMEDFDA UDI	Class IIa	Active
Orthos Accent Lfm Osgl Ndx -10tx22 L	515-0117	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Trimline Band Size 1	489-0001	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Ls 016x022 Nd Ppak 10pk	227-9011	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Lr Wdx-20tx018	513-2104	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 M/G Hk Andrews Non G-Off 2/-22/0	339-2740	EUDAMEDFDA UDI	Class IIa	Active
L2l Damon Q .022 -11/+4/0 Lo Tq	491-6425	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm Weldable Med Ul 2bi -8t 4a .018	154-4511	EUDAMEDFDA UDI	Class IIa	Active
U7r Ti-Orthos .018 -10/0/6	448-0202	EUDAMEDFDA UDI	Class IIa	Active
Bite Turbo Bracket Assy	350-0000	EUDAMEDFDA UDI	Class IIa	Active
U7r Db/Ul 22 Andrews T2 Pa Cap 2/-14/14	438-0080	EUDAMED	Class IIa	Active
Upper Right Ultimax Band Size 15	457-0115	EUDAMEDFDA UDI	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0017	EUDAMEDFDA UDI	Class IIa	Active
Lower Right First Molar Std High Retention Band Size 1	653-0101	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 26	652-0026	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Second Molar Std High Retention Band Size 32	652-0032	EUDAMEDFDA UDI	Class IIa	Active
Lower Left First Molar Washbon Band Size 2	374-0002	EUDAMEDFDA UDI	Class IIa	Active
Orthos Cm B/T Ufm 12dbl -10x022 Lt	342-0036	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.