K063386 is an FDA 510(k) clearance for the LORENZ ORTHODONTIC ANCHORAGE SYSTEM. This device is classified as a Implant, Endosseous, Orthodontic (Class II - Special Controls, product code OAT).
Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 9, 2007, 93 days after receiving the submission on November 8, 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 | K063386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2006 |
| Decision Date | February 09, 2007 |
| Days to Decision | 93 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. |