The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for Dentis S-clean Abutment Mini.
| Device ID | K220440 |
| 510k Number | K220440 |
| Device Name: | Dentis S-Clean Abutment Mini |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR 42718 |
| Contact | Gyu Ri Kim |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-16 |
| Decision Date | 2022-06-16 |