Is this your brand? Sign in to claim ownership.

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 24 of 134

Device	Model / Reference	Registries	Class	Status
Upper Right Second Molar Std High Retention Band Size 29	651-0029	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Std High Retention Band Size 24	651-0124	EUDAMEDFDA UDI	Class IIa	Active
Casing-Crown Assy-Advansync 2 Repl L6r Size 6 Pk5	600-4236	EUDAMEDFDA UDI	Class IIa	Active
Arch Tma Rev.curve Lwr 019x025 Pk/10	216-0005	EUDAMEDFDA UDI	Class IIa	Active
Damon Align Se200 16x25 Nd Ppak 10pk	227-1009	EUDAMEDFDA UDI	Class IIa	Active
U5l Ti-Orthos G-Off .022 -8/+4/0	449-6511	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 27 Baf .019x.025u/L Pk10	210-0915	EUDAMEDFDA UDI	Class IIa	Active
U7r Db/Ul 18 Roth Mt Hk 0/-14/14	437-0048	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Db/Ul 18 Roth Bhk 0/-22/4	428-1710	EUDAMEDFDA UDI	Class IIa	Active
L7r Db/Ul 22 Andrews T2 Pa -1/-31/4	438-0028	EUDAMED	Class IIa	Active
Twn Bkt Wedge Wid Lwr 1stbic-17trq018	170-0124	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Ultimax Band Size 7	460-0107	EUDAMEDFDA UDI	Class IIa	Active
Insignia Clear Sl 5-5 Single Patient Kit	728-0081	EUDAMEDFDA UDI	Class IIa	Active
Mini Diamond Ntwn Urlat +14t +8a 022	351-0280	EUDAMEDFDA UDI	Class IIa	Active
Optiband Ultra, 10 Syringe Kit, Blue Color 2-1491	740-0294	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Lrcusp -11t +6a 018	303-0442	EUDAMED	Class IIa	Active
LOWER RIGHT AND LEFT 1st MOLAR TRIMLINE BAND SIZE 5-36	434-0012	EUDAMEDFDA UDI	Class IIa	Active
L4r Minitwin Rec Db/Ul 18 Roth 0/-17/4	428-0610	EUDAMEDFDA UDI	Class IIa	Active
Vectortas Single Delta 10mm 150g Spring W/Swivel -pk6	601-0031	EUDAMEDFDA UDI	Class IIa	Active
Prls 15 Ufm Combi B/T -10trq 22x45 Rt	196-0209	EUDAMEDFDA UDI	Class IIa	Active
Optixrt Twin Lo Cusp 0t 0a 022	351-0406	EUDAMEDFDA UDI	Class IIa	Active
Crown W/Cutout-Advansync 2 L6l Size 4 Pk5	600-4324	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn/Hk Lrcus -11t +6a022	304-1442	EUDAMED	Class IIa	Active
Damon Ss Posted 26mm 19x25 Nd Bulk10pk	227-1029	EUDAMEDFDA UDI	Class IIa	Active
Mini-Diamond Tw Urcen 1510120+7t+5a22	351-0120	EUDAMEDFDA UDI	Class IIa	Active
Peerless 5deg Sgllfm-22trqx022 Ll	187-0303	EUDAMEDFDA UDI	Class IIa	Active
Ling Tube Hz W/Lock-Hks 036x072 Ul/Lr	673-3672	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 22x28 Nd Ppak10pk	227-9009	EUDAMEDFDA UDI	Class IIa	Active
L7r Bkt 22 Roth Mt Hk -1/-30/4	138-0285	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Lr 1st Bi -8t3a G-Off .018	348-8812	EUDAMEDFDA UDI	Class IIa	Active
F/Bow Britegear Short #4 044 Black	200-0624	EUDAMEDFDA UDI	Class IIa	Active
U4&5l Damon Q2 Weldable 022 -11/+2/0 Std Tq	161-8891	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn Lr 1st Bi -11t 0a 18	303-0612	EUDAMED	Class IIa	Active
L5r Ti-Orthos G-Off W/Hk .022 -9/+3/0	449-6912	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 22 D/G Hk Roth G-Off 2bi -1/-22/4	339-1711	EUDAMEDFDA UDI	Class IIa	Active
Tma Broad Arch Lo Sml 0210 0250 Pk/10	211-0405	EUDAMEDFDA UDI	Class IIa	Active
5-5 U/L Damon Q Single Patient Kit: U3-3 High Tq, L2-2 Low Tq	740-1402	EUDAMEDFDA UDI	Class IIa	Active
Copper Niti 27 Baf .017x.025l/S Pk10	211-0903	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN XF US 18X25 NiTi ND 10PK	227-3342	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 4	376-0004	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Second Molar Std High Retention Band Size 6	651-0006	EUDAMEDFDA UDI	Class IIa	Active
Power Thread 25 Gray 25ft Pkg Assy	640-1025	EUDAMEDFDA UDI	Class IIa	Active
6.5mm Rectangular Tube Pk10 - Advansync 2	600-4281	EUDAMEDFDA UDI	Class IIa	Active
Orth Accent Uf/S 15sgl-10x022 Lt Ndx	342-5115	EUDAMEDFDA UDI	Class IIa	Active
L3r Damon Q2 022 +7/+5/0 Std Tq	491-8830	EUDAMEDFDA UDI	Class IIa	Active
Spacers 10 Pack 3mm	600-1003	EUDAMEDFDA UDI	Class IIa	Active
Spark 35 - Single Arch	728-3235-A	EUDAMED	Class IIa	Active
Lower Left Ultima Band Size 31	460-0031	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Ss Lm 017x025 Nd Ppak 10pk	227-9003	EUDAMEDFDA UDI	Class IIa	Active
Prls 2ndmol B/T 12deg -27t 018 Ndx Ll	516-2108	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kerr Italia Srl IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.