K111809 is an FDA 510(k) clearance for the SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS. This device is classified as a Implant, Endosseous, Orthodontic (Class II - Special Controls, product code OAT).
Submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on September 26, 2011, 91 days after receiving the submission on June 27, 2011.
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 | K111809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2011 |
| Decision Date | September 26, 2011 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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. |