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Ormco/Sybronendo

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, recall (Z-1257-2020)Ormco/Sybronendo2020-02-06
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, recall (Z-1258-2020)Ormco/Sybronendo2020-02-06
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root ca recall (Z-2836-2016)Ormco/Sybronendo2016-09-16
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. recall (Z-0343-2016)Ormco/Sybronendo2015-11-30
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Pr recall (Z-1330-2014)Ormco/Sybronendo2014-04-04
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot N recall (Z-1321-2014)Ormco/Sybronendo2014-04-02
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Sc recall (Z-2194-2013)Ormco/Sybronendo2013-09-12
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S recall (Z-1544-2013)Ormco/Sybronendo2013-06-14
SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 13 recall (Z-1545-2013)Ormco/Sybronendo2013-06-14
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are recall (Z-1084-2013)Ormco/Sybronendo2013-04-10
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted recall (Z-0765-2013)Ormco/Sybronendo2013-02-01
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. recall (Z-0205-2013)Ormco/Sybronendo2012-11-05
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part N recall (Z-0120-2013)Ormco/Sybronendo2012-10-23

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Every clearance here is in the API, with alerts when new ones post.