The following data is part of a premarket notification filed by Talladium, Inc. with the FDA for Luminesse Pre-sintered Zirconia Coloring Liquid.
| Device ID | K143090 |
| 510k Number | K143090 |
| Device Name: | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID |
| Classification | Powder, Porcelain |
| Applicant | TALLADIUM, INC. 27360 WEST MUIRFIELD LN. Valencia, CA 91355 |
| Contact | Elina Faskhutdinova |
| Correspondent | Elina Faskhutdinova TALLADIUM, INC. 27360 WEST MUIRFIELD LN. 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 | 2014-10-28 |
| Decision Date | 2015-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D791CLOFAKIT0 | K143090 | 000 |
| D791252040 | K143090 | 000 |
| D791252030 | K143090 | 000 |
| D791252020 | K143090 | 000 |
| D791252010 | K143090 | 000 |
| D791252000 | K143090 | 000 |
| D7911904OL0 | K143090 | 000 |
| D7911904MLM0 | K143090 | 000 |
| D7911904MLL0 | K143090 | 000 |
| D7911904ML0 | K143090 | 000 |
| D7911904GL0 | K143090 | 000 |
| D791CLOFAMP0 | K143090 | 000 |
| D791CLOFALP0 | K143090 | 000 |
| D791CLOFALG0 | K143090 | 000 |
| D791CLOFADP0 | K143090 | 000 |
| D791252050 | K143090 | 000 |
| D791252060 | K143090 | 000 |
| D791252070 | K143090 | 000 |
| D791CLOFAA10 | K143090 | 000 |
| D791252200 | K143090 | 000 |
| D791252190 | K143090 | 000 |
| D791252180 | K143090 | 000 |
| D791252170 | K143090 | 000 |
| D791252160 | K143090 | 000 |
| D791252150 | K143090 | 000 |
| D791252140 | K143090 | 000 |
| D791252130 | K143090 | 000 |
| D791252120 | K143090 | 000 |
| D791252110 | K143090 | 000 |
| D791252100 | K143090 | 000 |
| D791252090 | K143090 | 000 |
| D791252080 | K143090 | 000 |
| D791CLOFADG0 | K143090 | 000 |