K061271 is an FDA 510(k) clearance for the ERCH ARCH BAR, MODEL 38-690-00. This device is classified as a Lock, Wire, And Ligature, Intraoral (Class II - Special Controls, product code DYX).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on June 30, 2006, 56 days after receiving the submission on May 5, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4600.
| 510(k) Number | K061271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2006 |
| Decision Date | June 30, 2006 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYX — Lock, Wire, And Ligature, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4600 |