The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Cmi Implant Is System.
| Device ID | K113554 |
| 510k Number | K113554 |
| Device Name: | CMI IMPLANT IS SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276763501 | K113554 | 000 |
| 08809276764249 | K113554 | 000 |
| 08809276764201 | K113554 | 000 |
| 08809276764188 | K113554 | 000 |
| 08809276764164 | K113554 | 000 |
| 08809276764140 | K113554 | 000 |
| 08809276764126 | K113554 | 000 |
| 08809276764102 | K113554 | 000 |
| 08809276764089 | K113554 | 000 |
| 08809276764065 | K113554 | 000 |
| 08809276764041 | K113554 | 000 |
| 08809276764027 | K113554 | 000 |
| 08809276764003 | K113554 | 000 |
| 08809276763969 | K113554 | 000 |
| 08809276763945 | K113554 | 000 |
| 08809276763921 | K113554 | 000 |
| 08809276763907 | K113554 | 000 |
| 08809276763884 | K113554 | 000 |
| 08809276764263 | K113554 | 000 |
| 08809276764287 | K113554 | 000 |
| 08809276763822 | K113554 | 000 |
| 08809276763808 | K113554 | 000 |
| 08809276763785 | K113554 | 000 |
| 08809276763761 | K113554 | 000 |
| 08809276763747 | K113554 | 000 |
| 08809276763723 | K113554 | 000 |
| 08809276763709 | K113554 | 000 |
| 08809276763686 | K113554 | 000 |
| 08809276763662 | K113554 | 000 |
| 08809276763648 | K113554 | 000 |
| 08809276763624 | K113554 | 000 |
| 08809276763600 | K113554 | 000 |
| 08809276763587 | K113554 | 000 |
| 08809276763563 | K113554 | 000 |
| 08809276763549 | K113554 | 000 |
| 08809276763525 | K113554 | 000 |
| 08809276769541 | K113554 | 000 |
| 08809276763860 | K113554 | 000 |