K191041 is an FDA 510(k) clearance for the Orthodontic Fixation Screw [Smart Anchor Miniscrew]. This device is classified as a Implant, Endosseous, Orthodontic (Class II - Special Controls, product code OAT).
Submitted by Gni Co., Ltd. (Hwaseong, KR). The FDA issued a Cleared decision on August 28, 2020, 497 days after receiving the submission on April 19, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640. It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed..
| 510(k) Number | K191041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2019 |
| Decision Date | August 28, 2020 |
| Days to Decision | 497 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OAT - Implant, Endosseous, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |
| Definition | It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed. |