Band, Elastic, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (25 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in ECI
| Company | 510(k)s | Recalls |
|---|---|---|
| A Company, Inc. | 5 | 0 |
| Glenroe Technologies | 4 | 0 |
| Jon-Ko Products, Inc. | 4 | 0 |
| G & H Wire Company | 0 | 2 |
| Unitek Corp. | 2 | 0 |
| American Orthodontics | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Bioseal | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Gac Intl., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | G & H Wire Company FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap,
Ref: AMD56 Open, Classified |
ECI | None listed |
| Jan 21, 2021 | G & H Wire Company Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic tre Terminated |
ECI | None listed |
| Oct 5, 2011 | Biomet Microfixation, Inc. Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOME Terminated |
ECI | None listed |
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