The following data is part of a premarket notification filed by Csm Implant Co., Ltd with the FDA for Apolonia Laser Implant System.
| Device ID | K102635 |
| 510k Number | K102635 |
| Device Name: | APOLONIA LASER IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CSM IMPLANT CO., LTD 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang CSM IMPLANT 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 | 2010-09-13 |
| Decision Date | 2011-03-22 |
| Summary: | summary |