The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diafil & Diafil Capsule.
Device ID | K192510 |
510k Number | K192510 |
Device Name: | DIAFIL & DIAFIL Capsule |
Classification | Material, Tooth Shade, Resin |
Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, KR 28161 |
Contact | Kab Sun Lee |
Correspondent | Kab Sun Lee Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, KR 28161 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-12 |
Decision Date | 2020-03-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806383564915 | K192510 | 000 |
08806383565103 | K192510 | 000 |
08806383565097 | K192510 | 000 |
08806383565035 | K192510 | 000 |
08806383565028 | K192510 | 000 |
08806383565011 | K192510 | 000 |
08806383565004 | K192510 | 000 |
08806383564991 | K192510 | 000 |
08806383564984 | K192510 | 000 |
08806383564977 | K192510 | 000 |
08806383564960 | K192510 | 000 |
08806383564953 | K192510 | 000 |
08806383564946 | K192510 | 000 |
08806383564939 | K192510 | 000 |
08806383565110 | K192510 | 000 |
08806383565127 | K192510 | 000 |
08806383575720 | K192510 | 000 |
08806383575713 | K192510 | 000 |
08806383575706 | K192510 | 000 |
08806383575690 | K192510 | 000 |
08806383575683 | K192510 | 000 |
08806383575676 | K192510 | 000 |
08806383575669 | K192510 | 000 |
08806383575652 | K192510 | 000 |
08806383575645 | K192510 | 000 |
08806383575638 | K192510 | 000 |
08806383575621 | K192510 | 000 |
08806383575614 | K192510 | 000 |
08806383565134 | K192510 | 000 |
08806383564922 | K192510 | 000 |