The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for T2.
| Device ID | K212303 |
| 510k Number | K212303 |
| Device Name: | T2 |
| 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 | Jinwoo Bae |
| Correspondent | Peter Lee Hiossen Inc. 85 Ben Fairless Dr. 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 | 2021-07-23 |
| Decision Date | 2021-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000995618 | K212303 | 000 |
| 08800000995601 | K212303 | 000 |