The following data is part of a premarket notification filed by 1derful, Inc with the FDA for 1derful Hs, 1derful Ht.
| Device ID | K210884 |
| 510k Number | K210884 |
| Device Name: | 1Derful HS, 1Derful HT |
| Classification | Powder, Porcelain |
| Applicant | 1Derful, Inc 38345 Donigan Road Brookshire, TX 77423 |
| Contact | Mohamad Alkassab |
| Correspondent | Robin Carden RAC Dental Technologies 27134 Paseo Espada, B201 San Juan Capistrano, CA 92675 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-25 |
| Decision Date | 2021-07-27 |