Wire, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (30 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in DZC
| Company | 510(k)s | Recalls |
|---|---|---|
| Highland Metals | 7 | 2 |
| Ultimate Wireforms, Inc. | 5 | 0 |
| Gac Intl., Inc. | 3 | 0 |
| A Company, Inc. | 2 | 0 |
| Berkley and Co. | 2 | 0 |
| Dentauraum, Inc. | 2 | 0 |
| Flexmedics | 2 | 0 |
| Ormco Corp. | 1 | 1 |
| Albert J. Anthony, Dmd | 1 | 0 |
| Arthur L. Wool | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Feb 3, 2014 | Highland Metals, Inc. SuperElastic Regular force NiTi lower or upper Natural arches.
0.14 size
10 or 100 count packages.
Highland Metals Inc.
San Jose, CA
The devices are intended to provide force to the teeth to effect Terminated |
DZC | None listed |
| Feb 3, 2014 | Highland Metals, Inc. SuperElastic Regular force NiTi lower or upper Natural arches.
0.16 size
10 or 100 count packages.
Highland Metals Inc.
San Jose, CA
The devices are intended to provide force to the teeth to effect Terminated |
DZC | None listed |
| Jan 11, 2012 | Ormco Corporation TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment. Terminated |
DZC | None listed |
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