The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Osstem Abutment System.
| Device ID | K221684 |
| 510k Number | K221684 |
| Device Name: | Osstem Abutment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 48002 |
| Contact | Seungju Kang |
| Correspondent | Peter Lee HiOSSEN Inc. 85 Ben Fairless Drive 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 | 2022-06-10 |
| Decision Date | 2022-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800121740135 | K221684 | 000 |
| 08809892356873 | K221684 | 000 |
| 08809892356965 | K221684 | 000 |
| 08809892357030 | K221684 | 000 |
| 08809892358914 | K221684 | 000 |
| 08800121727952 | K221684 | 000 |
| 08800121727969 | K221684 | 000 |
| 08800121733649 | K221684 | 000 |
| 08800121733656 | K221684 | 000 |
| 08800121733663 | K221684 | 000 |
| 08800121733670 | K221684 | 000 |
| 08800121740111 | K221684 | 000 |
| 08800121740128 | K221684 | 000 |
| 08809892356804 | K221684 | 000 |