The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Pre-milled Abutment Mini.
| Device ID | K210410 |
| 510k Number | K210410 |
| Device Name: | S-Clean Pre-Milled 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 | 2021-02-11 |
| Decision Date | 2021-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800053033732 | K210410 | 000 |
| 08800053033725 | K210410 | 000 |
| 08800053033718 | K210410 | 000 |
| 08800053033701 | K210410 | 000 |
| 08800053033695 | K210410 | 000 |
| 08800053033688 | K210410 | 000 |
| 08800053033671 | K210410 | 000 |
| 08800053033664 | K210410 | 000 |