The following data is part of a premarket notification filed by Kodent, Inc. with the FDA for Bio 60.
| Device ID | K041378 |
| 510k Number | K041378 |
| Device Name: | BIO 60 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | KODENT, INC. 9778 KATELLA AVE. STE 215 Anaheim, CA 92804 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu Chang KODENT, INC. 9778 KATELLA AVE. STE 215 Anaheim, CA 92804 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-08-02 |
| Summary: | summary |