K182193 is an FDA 510(k) clearance for the S-Line. This device is classified as a Bracket, Ceramic, Orthodontic (Class II - Special Controls, product code NJM).
Submitted by Biocetec Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 22, 2019, 161 days after receiving the submission on August 14, 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 | K182193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2018 |
| Decision Date | January 22, 2019 |
| Days to Decision | 161 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. |