The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for T1-cs, T1-c.
| Device ID | K183475 |
| 510k Number | K183475 |
| Device Name: | T1-CS, T1-C |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Osstem Implant Co., Ltd. 2 Floor, B-dong, 51, Mayu-ro 238beon-gil Siheung-si, KR 15079 |
| Contact | Jiyoon Ha |
| Correspondent | Peter Lee Hiossen Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000995793 | K183475 | 000 |
| 08800000995526 | K183475 | 000 |