K112640 is an FDA 510(k) clearance for the HYPERELASTIC WIRE. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).
Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on November 16, 2011, 65 days after receiving the submission on September 12, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K112640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2011 |
| Decision Date | November 16, 2011 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZC — Wire, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |