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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2020 | Ormco/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 |
DZD | None listed |
| Feb 6, 2020 | Ormco/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 |
DZD | None listed |
| Jan 14, 2020 | Ormco/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 |
EJF | None listed |
| Dec 27, 2017 | Ormco/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 |
EKR | K031664 |
| Sep 16, 2016 | Ormco/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 |
KIF | K010940 |
| Feb 8, 2016 | Ormco/Sybronendo TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541
Intended to fill a endontontically obturated root canal treatment Terminated |
EKM | None listed |
| Nov 30, 2015 | Ormco/Sybronendo Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement. Terminated |
DZC | None listed |
| Apr 4, 2014 | Ormco/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 |
DYW | K943245 |
| Apr 2, 2014 | Ormco/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 |
EJF | None listed |
| Sep 12, 2013 | Ormco/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 |
OAT | None listed |
| Jun 14, 2013 | Ormco/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 |
EKR | K031664 |
| Jun 14, 2013 | Ormco/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 |
EKR | K031664 |
| Apr 10, 2013 | Ormco/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 |
DZD | None listed |
| Feb 1, 2013 | Ormco/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 |
EKS | None listed |
| Nov 5, 2012 | Ormco/Sybronendo Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. Terminated |
DZN | None listed |
| Oct 23, 2012 | Ormco/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 |
EJF | None listed |