The following data is part of a premarket notification filed by Aurident, Inc. with the FDA for Radiance Porcelain.
| Device ID | K042638 |
| 510k Number | K042638 |
| Device Name: | RADIANCE PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | AURIDENT, INC. 610 S. STATE COLLEGE BLVD. Fullerton, CA 92831 |
| Contact | Bruce D Spivack |
| Correspondent | Bruce D Spivack AURIDENT, INC. 610 S. STATE COLLEGE BLVD. Fullerton, CA 92831 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-12-17 |
| Summary: | summary |