The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diatemp.
| Device ID | K192158 |
| 510k Number | K192158 |
| Device Name: | DiaTemp |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383565752 | K192158 | 000 |
| 08806383565745 | K192158 | 000 |
| 08806383565578 | K192158 | 000 |
| 08806383565561 | K192158 | 000 |