Tube, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (8 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in DZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Ormco/Sybronendo | 0 | 3 |
| Alexotek Co. | 2 | 0 |
| Aequitron Medical, Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Jon-Ko Products, Inc. | 1 | 0 |
| Ortho Organizers Inc | 0 | 1 |
| Ortho Specialties | 1 | 0 |
| Percussionaire Corp. | 1 | 0 |
| Rocky Mountain Orthodontics, Inc. | 1 | 0 |
| 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 |
| 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 15, 2011 | Ortho Organizers Inc ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each);
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB U Terminated |
DZD | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.