The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Ezfil.
| Device ID | K191991 |
| 510k Number | K191991 |
| Device Name: | Ezfil |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Meta Biomed Co., Ltd. 270, Osong Saengmyeong 1-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Suk Song Oh |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-25 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387894339 | K191991 | 000 |
| 08806387894162 | K191991 | 000 |
| 08806387894179 | K191991 | 000 |
| 08806387894186 | K191991 | 000 |
| 08806387894193 | K191991 | 000 |
| 08806387894209 | K191991 | 000 |
| 08806387894216 | K191991 | 000 |
| 08806387894223 | K191991 | 000 |
| 08806387894230 | K191991 | 000 |
| 08806387894247 | K191991 | 000 |
| 08806387894254 | K191991 | 000 |
| 08806387894261 | K191991 | 000 |
| 08806387894278 | K191991 | 000 |
| 08806387894285 | K191991 | 000 |
| 08806387894292 | K191991 | 000 |
| 08806387894308 | K191991 | 000 |
| 08806387894315 | K191991 | 000 |
| 08806387894322 | K191991 | 000 |
| 08806387894155 | K191991 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EZFIL 86153371 4740079 Live/Registered |
FOXX LIFE SCIENCES, LLC 2013-12-27 |
![]() EZFIL 85109335 not registered Dead/Abandoned |
Roush Life Sciences, LLC 2010-08-17 |