K200148 is an FDA 510(k) clearance for the LightForce Orthodontic System (LFO System). This device is classified as a Bracket, Ceramic, Orthodontic (Class II - Special Controls, product code NJM).
Submitted by Lightforce Orthodontics (Cambridge, US). The FDA issued a Cleared decision on February 21, 2020, 30 days after receiving the submission on January 22, 2020.
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 | K200148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2020 |
| Decision Date | February 21, 2020 |
| Days to Decision | 30 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. |