The following data is part of a premarket notification filed by Osstem Implant Co., Ltd with the FDA for Multi Angled Abutment.
| Device ID | K123755 |
| 510k Number | K123755 |
| Device Name: | MULTI ANGLED ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OSSTEM IMPLANT CO., LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-04-26 |
| Summary: | summary |