The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Cmi Implant Is Ii Active.
| Device ID | K120503 |
| 510k Number | K120503 |
| Device Name: | CMI IMPLANT IS II ACTIVE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEOBIOTECH CO., LTD. 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee NEOBIOTECH CO., LTD. 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276764294 | K120503 | 000 |
| 08809276763877 | K120503 | 000 |
| 08809276763839 | K120503 | 000 |
| 08809276763815 | K120503 | 000 |
| 08809276763792 | K120503 | 000 |
| 08809276763778 | K120503 | 000 |
| 08809276763754 | K120503 | 000 |
| 08809276763730 | K120503 | 000 |
| 08809276763716 | K120503 | 000 |
| 08809276763693 | K120503 | 000 |
| 08809276763679 | K120503 | 000 |
| 08809276763655 | K120503 | 000 |
| 08809276763631 | K120503 | 000 |
| 08809276763617 | K120503 | 000 |
| 08809276763594 | K120503 | 000 |
| 08809276763570 | K120503 | 000 |
| 08809276763556 | K120503 | 000 |
| 08809276763532 | K120503 | 000 |
| 08809276763891 | K120503 | 000 |
| 08809276763914 | K120503 | 000 |
| 08809276764270 | K120503 | 000 |
| 08809276764256 | K120503 | 000 |
| 08809276764232 | K120503 | 000 |
| 08809276764218 | K120503 | 000 |
| 08809276764195 | K120503 | 000 |
| 08809276764171 | K120503 | 000 |
| 08809276764157 | K120503 | 000 |
| 08809276764133 | K120503 | 000 |
| 08809276764119 | K120503 | 000 |
| 08809276764096 | K120503 | 000 |
| 08809276764072 | K120503 | 000 |
| 08809276764058 | K120503 | 000 |
| 08809276764034 | K120503 | 000 |
| 08809276764010 | K120503 | 000 |
| 08809276763976 | K120503 | 000 |
| 08809276763952 | K120503 | 000 |
| 08809276763938 | K120503 | 000 |
| 08809276763518 | K120503 | 000 |