The following data is part of a premarket notification filed by Tanaka Dental with the FDA for Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid And Tanaka Enamel Zr Blocks.
| Device ID | K140491 |
| 510k Number | K140491 |
| Device Name: | TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS |
| Classification | Powder, Porcelain |
| Applicant | TANAKA DENTAL 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown TANAKA DENTAL 8944 TAMAROA TERRACE Skokie, IL 60076 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2015-05-20 |
| Summary: | summary |