The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Prelude One.
| Device ID | K090106 |
| 510k Number | K090106 |
| Device Name: | PRELUDE ONE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-01 |
| Decision Date | 2009-03-31 |
| Summary: | summary |