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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 134 of 134

Device	Model / Reference	Registries	Class	Status
U4&5r Damon Q Weldable .022 -11/+2/0 Std Tq	161-8490	EUDAMEDFDA UDI	Class IIa	Active
Lower Right Second Molar Std High Retention Band Size 21	653-0021	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultimax Band Size 10	460-0110	EUDAMEDFDA UDI	Class IIa	Active
Symetri Clear Mclaughlin, Bennett & Trevisi Upper 5-5 With Hooks On 3 .018	746-2105	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Db/Ul 22 Roth Of/Gv 0/-22/4	429-0770	EUDAMEDFDA UDI	Class IIa	Active
L1l Titanium Orthos Bios .022 -10/+2/0	449-8617	EUDAMEDFDA UDI	Class IIa	Active
U1l Twin Db/Mm 22 Suptq 5/17	364-1041	EUDAMED	Class IIa	Active
L4l Minitwin Db/Ul 18 Andrews Of/Gv 0/-17	428-0671	EUDAMEDFDA UDI	Class IIa	Active
Orthos Bios Ul Cent 22t 5a .018	348-6119	EUDAMEDFDA UDI	Class IIa	Active
U2r Twin Db/Mm 22 Set Iii/Roth 9/8	364-1027	EUDAMED	Class IIa	Active
U4&5l Comfort Bkt 18 0/-7	163-3022	EUDAMED	Class IIa	Active
Upper Left Ultima Band Size 17	458-0017	EUDAMEDFDA UDI	Class IIa	Active
Universal Upper Bicuspid Band With Lug Size 17	331-0317	EUDAMEDFDA UDI	Class IIa	Active
Long Handle Micro Mini Pin & Ligature Cutter	803-0512	EUDAMED	Class I	Active
Micro Mini Pin & Ligature Cutter	803-0502	EUDAMED	Class I	Active
L7l Bkt 22 Andrews T3 Pa -2/-31/6	137-0281	EUDAMEDFDA UDI	Class IIa	Active
UP/LO 4&5 UNIV STb LIGHT LINGUAL .018 0/0/0 HK	369-3401	EUDAMEDFDA UDI	Class IIa	Active
Twn Bkt Wedge Med Lwr 1stbic-17trq022	170-0121	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Washbon Band Size 22	378-0022	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 40 Baf.019x.025up Sm Pk10	210-0945	EUDAMEDFDA UDI	Class IIa	Active
Universal Lower Bicuspid Band With Lug Size 18	332-0318	EUDAMEDFDA UDI	Class IIa	Active
U4&5r Twin Bkt 18 Roth Mbhk 0/-7/2	163-1079	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultima Band Size 18	458-0018	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Trimline Band Size 24	486-0024	EUDAMEDFDA UDI	Class IIa	Active
Etm8014 Smaha Slimline Sure-Grip Cvd	800-8014	EUDAMEDFDA UDI	Class I	Active
Refill Unidose - Blugloo	740-0273	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.