K163251 is an FDA 510(k) clearance for the Life Essence Universal Porcelain System. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Blue Sky Bio (Grayslake, US). The FDA issued a Cleared decision on August 4, 2017, 259 days after receiving the submission on November 18, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K163251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2016 |
| Decision Date | August 04, 2017 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |