ClearanceBrief
Company

Ormco/Sybronendo

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
5recalls that name a 510(k)

Product codes

CodeDeviceRecords
DZDTube, Orthodontic3
EJFBracket, Metal, Orthodontic3
EKRPlugger, Root Canal, Endodontic3
DYWBracket, Plastic, Orthodontic1
DZCWire, Orthodontic1
DZNInstruments, Dental Hand1
EKMGutta-Percha1
EKSFile, Pulp Canal, Endodontic1
KIFResin, Root Canal Filling1
OATImplant, Endosseous, Orthodontic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 6, 2020Ormco/Sybronendo
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Terminated
DZDNone listed
Feb 6, 2020Ormco/Sybronendo
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Terminated
DZDNone listed
Jan 14, 2020Ormco/Sybronendo
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of te
Terminated
EJFNone listed
Dec 27, 2017Ormco/Sybronendo
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of
Terminated
EKRK031664
Sep 16, 2016Ormco/Sybronendo
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of
Terminated
KIFK010940
Feb 8, 2016Ormco/Sybronendo
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Terminated
EKMNone listed
Nov 30, 2015Ormco/Sybronendo
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Terminated
DZCNone listed
Apr 4, 2014Ormco/Sybronendo
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an arc
Terminated
DYWK943245
Apr 2, 2014Ormco/Sybronendo
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Terminated
EJFNone listed
Sep 12, 2013Ormco/Sybronendo
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate th
Terminated
OATNone listed
Jun 14, 2013Ormco/Sybronendo
SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA),
Terminated
EKRK031664
Jun 14, 2013Ormco/Sybronendo
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Ita
Terminated
EKRK031664
Apr 10, 2013Ormco/Sybronendo
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
Terminated
DZDNone listed
Feb 1, 2013Ormco/Sybronendo
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic ins
Terminated
EKSNone listed
Nov 5, 2012Ormco/Sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Terminated
DZNNone listed
Oct 23, 2012Ormco/Sybronendo
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX B
Terminated
EJFNone listed
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