The following data is part of a premarket notification filed by Biogenesis Co., Ltd. with the FDA for Biogenesis Implant System.
| Device ID | K120089 |
| 510k Number | K120089 |
| Device Name: | BIOGENESIS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOGENESIS CO., LTD. 1515 EAST KATELLA AVENUE UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung BIOGENESIS CO., LTD. 1515 EAST KATELLA AVENUE UNIT 2115 Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-11 |
| Decision Date | 2013-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800024917771 | K120089 | 000 |
| 08800024917764 | K120089 | 000 |