K142848 is an FDA 510(k) clearance for the EAZY PRIMER. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on February 24, 2015, 147 days after receiving the submission on September 30, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K142848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2014 |
| Decision Date | February 24, 2015 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |