The following data is part of a premarket notification filed by Kuraray America, Inc. with the FDA for Chroma Zone Color Stain.
| Device ID | K982259 |
| 510k Number | K982259 |
| Device Name: | CHROMA ZONE COLOR STAIN |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KURARAY AMERICA, INC. 200 PARK AVE. New York, NY 10166 -3098 |
| Contact | Koji Fujita |
| Correspondent | Koji Fujita KURARAY AMERICA, INC. 200 PARK AVE. New York, NY 10166 -3098 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-09-22 |
| Summary: | summary |