Bracket, Metal, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (103 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in EJF
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 22 | 0 |
| Ormco Corp. | 8 | 2 |
| Flexmedics | 7 | 0 |
| Lancer Orthodontics, Inc. | 7 | 0 |
| Gac Intl., Inc. | 5 | 0 |
| Masel Industries, Inc. | 4 | 0 |
| Ortho Organizers, Inc. | 2 | 2 |
| Unitek Corp. | 4 | 0 |
| Ormco/Sybronendo | 0 | 3 |
| A Company, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Apr 2, 2019 | Ortho Organizers, Inc. Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only
(01)00190707017064 (10)889437 (422)484
Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only
(01)00190707017071(10)889437 (422)484 Terminated |
EJF | None listed |
| Apr 2, 2019 | Ortho Organizers, Inc. Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only
(01)00190707016517 (10)112233 (422)484 Terminated |
EJF | None listed |
| 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 |
| Feb 22, 2013 | Ultradent Products, Inc. Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017,
Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechan Terminated |
EJF | K922499 |
| 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 |
| Mar 1, 2012 | Ormco Corporation Brand name: Orthos CM Bracket, Orthodontic Metal Bracket,
Part Numbers: 454-1210, 454-0210.
The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic Terminated |
EJF | None listed |
| Dec 15, 2004 | Ormco Corporation Titanium Orthos Bracket Terminated |
EJF | None listed |
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