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 |