The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Sq-sl Implant System Mini.
| Device ID | K200099 |
| 510k Number | K200099 |
| Device Name: | S-Clean SQ-SL Implant System Mini |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR |
| Contact | Gyu Ri Kim |
| Correspondent | April Lee Withus Group Inc. 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2020-04-13 |