The following data is part of a premarket notification filed by Candulor Usa, Inc. with the FDA for Direct Crown Natural 1.
| Device ID | K101814 |
| 510k Number | K101814 |
| Device Name: | DIRECT CROWN NATURAL 1 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | CANDULOR USA, INC. 7462 N. FIGUEROA STREET SUITE 104 Los Angeles, CA 90041 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett CANDULOR USA, INC. 7462 N. FIGUEROA STREET SUITE 104 Los Angeles, CA 90041 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-09-27 |