Ormco/Sybronendo

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1257-2020Class IISnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in MeJanuary 17, 2020
Z-1258-2020Class IISnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in MeJanuary 17, 2020
Z-2286-2020Class IIOrmco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. MaJanuary 14, 2020
Z-0413-2018Class IIElements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodonDecember 27, 2017
Z-2836-2016Class IISealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filAugust 31, 2016
Z-1083-2016Class IITF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontonticallFebruary 8, 2016
Z-0343-2016Class IICopper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended November 4, 2015
Z-1321-2014Class IITitanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121March 25, 2014
Z-1330-2014Class IISpirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product UMarch 25, 2014
Z-2194-2013Class IIBrand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw July 12, 2013
Z-1084-2013Class IIBracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are iMarch 8, 2013
Z-1544-2013Class IISybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone HiJanuary 17, 2013
Z-1545-2013Class IISybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. LonJanuary 17, 2013
Z-0765-2013Class IISybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part December 12, 2012
Z-0120-2013Class IIIThe brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494April 24, 2012
Z-0205-2013Class IIVector TAS Modular Driver, a manual driver for Vector TAS dental screws.December 12, 2011