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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 125 of 134

Device	Model / Reference	Registries	Class	Status
5-5 U/L Damon Q Single Patient Kit: Std Tq	740-1400	EUDAMEDFDA UDI	Class IIa	Active
U5r Orthos Bic Tube G-Off 18 -8/4	454-1520	EUDAMED	Class IIa	Active
Lingual Ball Hook Short 1-1010	242-0005	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALGN SE200 LM 016 NiTi ND 10PK	227-3132	EUDAMEDFDA UDI	Class IIa	Active
L3r Minitwin Db/Mtwin 18 Roth 7/-11/2 Bhk	328-1410	EUDAMEDFDA UDI	Class IIa	Active
Prlss 2nd B/T 6deg -20t 018 Ndx Ll	340-6317	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp35d 020x020 Ul W/Stops Pk10	227-1322	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Std High Retention Band Size 2	654-0002	EUDAMEDFDA UDI	Class IIa	Active
Alex.signature Bracket Lwr 2bi -9 0a .018	154-3725	EUDAMED	Class IIa	Active
F/Bow Britegear Short #4 044 Orange	200-0524	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5dbl Lfm -27tx22x21 Rt	520-0231	EUDAMEDFDA UDI	Class IIa	Active
Lower Left Second Molar Washbon Band Size 31	376-0031	EUDAMEDFDA UDI	Class IIa	Active
Minidiamnd Ulcus 1500341 Whk+7t+10a18	350-1341	EUDAMEDFDA UDI	Class IIa	Active
7-7 U/L Damon Ultima Single Patient Kit Neutral Torque, Snaplink, And Ti Tubes	740-1442	EUDAMEDFDA UDI	Class IIa	Active
Tru-Arch Cuniti Non-Dimp35d 017x025 Ll W/Stops Pk10	227-1314	EUDAMEDFDA UDI	Class IIa	Active
DQ SPK 5: U5-5 STD TQ, 6/7 Tubes	740-1505	EUDAMED	Class IIa	Active
Opt Miniwick Med Goff Upbic -7t 0a 018	350-3524	EUDAMEDFDA UDI	Class IIa	Active
L4l Attract Db/Am 22 Andrews 2/-17	364-7040	EUDAMED	Class IIa	Active
Spark 20 Combo - Refinement	728-3022-SC	EUDAMED	Class IIa	Active
Orthos Cm Niti Arch.016 Dia Uplg Pk10	219-3403	EUDAMEDFDA UDI	Class IIa	Active
U6r Tbbt Bkt 2245 Bioprog Mt Hk 0/-10/15	138-0129	EUDAMED	Class IIa	Active
Mini2000 Dmd Twn/Llcusp -11t +6a 022	304-0443	EUDAMED	Class IIa	Active
Facebow S/R Short Szlg .044 Dia.	200-0228	EUDAMEDFDA UDI	Class IIa	Active
U3l Damon Q2 022 +7/+5/0 Std Tq - Hook	491-9881	EUDAMEDFDA UDI	Class IIa	Active
Accent B/T 5sgl F/S Wdx -27tx18 Ll	515-0232	EUDAMEDFDA UDI	Class IIa	Active
U3l Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/8/0	418-1311	EUDAMEDFDA UDI	Class IIa	Active
Orthos Ap Ul Lat +9t 6a -3r .018	348-8211	EUDAMEDFDA UDI	Class IIa	Active
TRU-ARCH ALIGN SE200 LM 014 NiTi DIMPLE 10PK	227-3125	EUDAMEDFDA UDI	Class IIa	Active
Mini2000 Dmd Twn/Hk Lrcusp -7t +6a 18	303-1432	EUDAMED	Class IIa	Active
L5r Damon Ultima 22 Procline Tq	333-4520	EUDAMEDFDA UDI	Class IIa	Active
Upper Left First Molar Std High Retention Band Size 11	652-0111	EUDAMEDFDA UDI	Class IIa	Active
COPPER NiTi 35 BAF 20x20 LOLG PK/10	211-0937	EUDAMEDFDA UDI	Class IIa	Active
Ormesh Pix Tube .022 X 028 X 2mm Long	300-0099	EUDAMEDFDA UDI	Class IIa	Active
L5l Sws Db/Om 22 Roth Non G-Off -1/-22/4	339-0731	EUDAMEDFDA UDI	Class IIa	Active
L4l Twin Bkt 22 Andrews 2/-17	164-1051	EUDAMEDFDA UDI	Class IIa	Active
L6r Damon G-Off .022 -30t 2a 0do Hook	342-2021	EUDAMEDFDA UDI	Class IIa	Active
Upper Right First Molar Washbon Band Size 17	377-0017	EUDAMEDFDA UDI	Class IIa	Active
L5r Minitwin Rec Db/Ul 22 Andrews Bhk 0/-22	429-1720	EUDAMEDFDA UDI	Class IIa	Active
Arch P/F Edg.rect.lo.0160 X.0220 Pk10	209-1622	EUDAMEDFDA UDI	Class IIa	Active
Facebow S/R Super Short Szlg .044 Dia	200-0268	EUDAMEDFDA UDI	Class IIa	Active
Zoo Master Pouch 2g 3/16 8oz Cougar	634-0000	EUDAMEDFDA UDI	Class IIa	Active
L5r Sws Db/Om 22 D/G Hk Roth Non G-Off -1/-22/4	339-1730	EUDAMEDFDA UDI	Class IIa	Active
Upper Right Ultima Band Size 29	457-0029	EUDAMEDFDA UDI	Class IIa	Active
L3r Minitwin Db/Mtwin 18 Damon Rx 5/0 Bhk	328-1430	EUDAMEDFDA UDI	Class IIa	Active
Arch Ling.univ.tma .016 Dia. Pk 10	202-0025	EUDAMEDFDA UDI	Class IIa	Active
Peerless 2ndmol 6deg Ul Ndx-10t X 018	512-2210	EUDAMEDFDA UDI	Class IIa	Active
Arch Alexander Sz 2 Lwr 16 Rd Pk 10	207-0031	EUDAMEDFDA UDI	Class IIa	Active
Upper Left Ultimax Band Size 6	458-0106	EUDAMEDFDA UDI	Class IIa	Active
U3r Ti-Orthos .018 -3/+10/0	448-6310	EUDAMEDFDA UDI	Class IIa	Active
L5l Minitwin Rec Bkt Flng 22 Andrews 0/-22	164-2000	EUDAMEDFDA UDI	Class IIa	Active

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Kerr Italia Srl IT

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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.