The following data is part of a premarket notification filed by Osstem Implant Co Ltd with the FDA for Ziocera & Convertible System.
| Device ID | K081786 |
| 510k Number | K081786 |
| Device Name: | ZIOCERA & CONVERTIBLE SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OSSTEM IMPLANT CO LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Minjoo Kim |
| Correspondent | Minjoo Kim OSSTEM IMPLANT CO LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-24 |
| Decision Date | 2008-12-02 |
| Summary: | summary |