K123416 is an FDA 510(k) clearance for the INSIGNIA WITH ITERO. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on March 13, 2013, 127 days after receiving the submission on November 6, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K123416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2012 |
| Decision Date | March 13, 2013 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYW — Bracket, Plastic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |