The following data is part of a premarket notification filed by Osstem Co., Ltd. with the FDA for Avana Dental Implant System.
| Device ID | K051576 |
| 510k Number | K051576 |
| Device Name: | AVANA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM CO., LTD. 27001 LA PAZ ROAD, SUITE #312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego OSSTEM CO., LTD. 27001 LA PAZ ROAD, SUITE #312 Mission Viejo, CA 92691 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-09-01 |
| Summary: | summary |