The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diapex Plus.
Device ID | K182625 |
510k Number | K182625 |
Device Name: | Diapex Plus |
Classification | Resin, Root Canal Filling |
Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, KR 28161 |
Contact | Myung Sub Kim |
Correspondent | Myung Sub Kim Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, KR 28161 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-24 |
Decision Date | 2019-06-03 |