K180952 is an FDA 510(k) clearance for the Ceramic Bracket. This device is classified as a Bracket, Ceramic, Orthodontic (Class II - Special Controls, product code NJM).
Submitted by Mem Dental Technology Co., Ltd. (Tainan City, TW). The FDA issued a Cleared decision on June 7, 2019, 422 days after receiving the submission on April 11, 2018.
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 | K180952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2018 |
| Decision Date | June 07, 2019 |
| Days to Decision | 422 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. |