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 |