The following data is part of a premarket notification filed by Blue Sky Bio with the FDA for Life Essence Universal Porcelain System.
| Device ID | K163251 |
| 510k Number | K163251 |
| Device Name: | Life Essence Universal Porcelain System |
| Classification | Powder, Porcelain |
| Applicant | BLUE SKY BIO 888 E BELVEDERE RD SUITE 212 Grayslake, IL 60030 |
| Contact | Albert Zickmann |
| Correspondent | Angela Blackwell BLACKWELL DEVICE CONSULTING Grayslake, IL 60030 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-08-04 |
| Summary: | summary |