The following data is part of a premarket notification filed by Diadent Group International with the FDA for Dia-root Bio Sealer.
| Device ID | K200175 |
| 510k Number | K200175 |
| Device Name: | DIA-ROOT BIO Sealer |
| Classification | Resin, Root Canal Filling |
| Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, KR 28161 |
| Contact | Kab Sun Lee |
| Correspondent | Kab Sun Lee 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 | 2020-01-23 |
| Decision Date | 2020-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383565790 | K200175 | 000 |
| 08806383577946 | K200175 | 000 |