The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diapaste.
| Device ID | K190091 |
| 510k Number | K190091 |
| Device Name: | Diapaste |
| Classification | Resin, Root Canal Filling |
| Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, KR 28161 |
| Contact | Myung Sub Kim |
| Correspondent | Kab Sun Lee Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-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 | 2019-01-18 |
| Decision Date | 2020-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383564670 | K190091 | 000 |
| 08806383564663 | K190091 | 000 |
| 08806383564656 | K190091 | 000 |
| 08806383564649 | K190091 | 000 |
| 08806383564632 | K190091 | 000 |