The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Is-iii Active System_s-narrow Type.
| Device ID | K190849 |
| 510k Number | K190849 |
| Device Name: | IS-III Active System_S-narrow Type |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Neobiotech Co., Ltd. #312-1, 36, Digital-ro 27-Gil, Guro-gu Seoul, KR 08381 |
| Contact | Young-ku Heo |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809486296882 | K190849 | 000 |
| 08809486296769 | K190849 | 000 |
| 08809486296752 | K190849 | 000 |
| 08809486296745 | K190849 | 000 |
| 08809486296738 | K190849 | 000 |
| 08809486296721 | K190849 | 000 |
| 08809486296714 | K190849 | 000 |
| 08809486296707 | K190849 | 000 |
| 08809486296691 | K190849 | 000 |
| 08809486296776 | K190849 | 000 |
| 08809486296783 | K190849 | 000 |
| 08809486296790 | K190849 | 000 |
| 08809486296875 | K190849 | 000 |
| 08809486296868 | K190849 | 000 |
| 08809486296851 | K190849 | 000 |
| 08809486296844 | K190849 | 000 |
| 08809486296837 | K190849 | 000 |
| 08809486296820 | K190849 | 000 |
| 08809486296813 | K190849 | 000 |
| 08809486296806 | K190849 | 000 |
| 08809486296684 | K190849 | 000 |