The following data is part of a premarket notification filed by Osstem Implant Co., Ltd with the FDA for Transfer & Angled Abutment.
| Device ID | K153015 |
| 510k Number | K153015 |
| Device Name: | Transfer & Angled Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Osstem Implant Co., Ltd 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 612-070 |
| Contact | Hee Kwon |
| Correspondent | David Kim HiOSSEN Inc. 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 | 2015-10-15 |
| Decision Date | 2016-12-05 |
| Summary: | summary |