K173623 is an FDA 510(k) clearance for the Anchor plate. This device is classified as a Implant, Endosseous, Orthodontic (Class II - Special Controls, product code OAT).
Submitted by Biomaterials Korea, Inc. (Hanam-Si, KR). The FDA issued a Cleared decision on August 30, 2018, 279 days after receiving the submission on November 24, 2017.
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 | K173623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2017 |
| Decision Date | August 30, 2018 |
| Days to Decision | 279 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. |