The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diatemp Flow.
Device ID | K192022 |
510k Number | K192022 |
Device Name: | DiaTemp Flow |
Classification | Crown And Bridge, Temporary, 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 | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-29 |
Decision Date | 2020-02-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806383565776 | K192022 | 000 |
08806383565769 | K192022 | 000 |
08806383565592 | K192022 | 000 |
08806383565585 | K192022 | 000 |