K183018 is an FDA 510(k) clearance for the VPro5. This device is classified as a Orthodontic Vibratory Accessory (Class II - Special Controls, product code OYH).
Submitted by Propel Orthodontics, LLC (Milpitas, US). The FDA issued a Cleared decision on November 1, 2019, 366 days after receiving the submission on October 31, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. An Orthodontic Accessory Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Orthodontic Appliances Such As Braces And Helps Facilitate Minor Anterior Tooth Movement..
| 510(k) Number | K183018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2018 |
| Decision Date | November 01, 2019 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OYH - Orthodontic Vibratory Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | An Orthodontic Accessory Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Orthodontic Appliances Such As Braces And Helps Facilitate Minor Anterior Tooth Movement. |