K192767 is an FDA 510(k) clearance for the Clear Aligner. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Royal Dental Lab (Shenzhen, CN). The FDA issued a Cleared decision on January 8, 2020, 100 days after receiving the submission on September 30, 2019.
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 | K192767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | January 08, 2020 |
| Days to Decision | 100 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. |