K182658 is an FDA 510(k) clearance for the Bioliner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Five Star Orthodontic Lab & Supply (Denton, US). The FDA issued a Cleared decision on June 19, 2019, 267 days after receiving the submission on September 25, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K182658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2018 |
| Decision Date | June 19, 2019 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |