The following data is part of a premarket notification filed by Sb Lucius, Inc. with the FDA for Ceranum 82.
| Device ID | K023197 |
| 510k Number | K023197 |
| Device Name: | CERANUM 82 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 Anaheim, CA 92804 |
| Contact | Dae-kyu Chang |
| Correspondent | Dae-kyu Chang SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 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 | 2002-09-25 |
| Decision Date | 2002-11-05 |
| Summary: | summary |