The following data is part of a premarket notification filed by Talladium, Inc. with the FDA for Luminesse Shaded Zirconia Sz.
| Device ID | K152023 |
| 510k Number | K152023 |
| Device Name: | Luminesse Shaded Zirconia SZ |
| Classification | Powder, Porcelain |
| Applicant | TALLADIUM, INC. 27360 WEST MUIRFIELD LANE Valencia, CA 91355 |
| Contact | Edward Harms |
| Correspondent | Edward Harms TALLADIUM, INC. 27360 WEST MUIRFIELD LANE Valencia, CA 91355 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-21 |
| Decision Date | 2016-09-15 |
| Summary: | summary |