The following data is part of a premarket notification filed by Osstem Implant Co., Ltd with the FDA for Link Abutment For Cerec.
| Device ID | K160519 |
| 510k Number | K160519 |
| Device Name: | Link Abutment For CEREC |
| 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 | 2016-02-25 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000965437 | K160519 | 000 |
| 08800000965420 | K160519 | 000 |
| 08800000965413 | K160519 | 000 |
| 08800000965406 | K160519 | 000 |
| 00810019241734 | K160519 | 000 |
| 00810019241727 | K160519 | 000 |
| 00810019241710 | K160519 | 000 |
| 00810019241703 | K160519 | 000 |
| 00810019241697 | K160519 | 000 |