K061266 is an FDA 510(k) clearance for the ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR. This device is classified as a Implant, Endosseous, Orthodontic (Class II - Special Controls, product code OAT).
Submitted by Ortho Organizers, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2006, 87 days after receiving the submission on May 5, 2006.
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 | K061266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2006 |
| Decision Date | July 31, 2006 |
| Days to Decision | 87 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. |