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 |