K192202 is an FDA 510(k) clearance for the Clear21. This device is classified as a Bracket, Ceramic, Orthodontic (Class II - Special Controls, product code NJM).
Submitted by World Class Technology Corporation (Mcminnville, US). The FDA issued a Cleared decision on November 12, 2019, 90 days after receiving the submission on August 14, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position..
| 510(k) Number | K192202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2019 |
| Decision Date | November 12, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NJM - Bracket, Ceramic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position. |