The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diapaste.
Device ID | K210333 |
510k Number | K210333 |
Device Name: | DiaPaste |
Classification | Resin, Root Canal Filling |
Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
Contact | Kab Sun Lee |
Correspondent | Kab Sun Lee Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-05 |
Decision Date | 2021-03-25 |