The following data is part of a premarket notification filed by Diadent Group International with the FDA for Dia-x Bond Universal.
| Device ID | K220804 |
| 510k Number | K220804 |
| Device Name: | Dia-X Bond Universal |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383583138 | K220804 | 000 |
| 08806383583121 | K220804 | 000 |