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 |