Aligner, Sequential
Regulation 872.5470
6510(k)s in 12 months (145 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NXC
| Company | 510(k)s | Recalls |
|---|---|---|
| Align Technology | 12 | 0 |
| Clearcorrect, Inc. | 4 | 0 |
| Smylio, Inc. | 4 | 0 |
| 3M Company, Unitek Orthodontic Products | 3 | 0 |
| Blue Sky Bio, LLC | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Ormco Corporation | 3 | 0 |
| 3D Global Biotech, Inc. | 2 | 0 |
| 3M Company | 2 | 0 |
| Allesee Orthodontic Appliances | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2024 | 3M Company - Health Care Business Clarity Precision Grip Attachments, for use in orthodontic treatment.
Part numbers/SKUs:
359-830
359-831
359-832
359-833
359-834
359-835
359-836
359-837 Open, Classified |
NXC | K233257 |
| Dec 23, 2024 | Straight Smile, LLC BYTE Aligner System REF PRS-0063
BYTE All-Day Aligner System
BYTE AT-Night Aligner System
A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self Open, Classified |
NXC | K230199 |
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