The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Pre-milled Abutment.
| Device ID | K210362 |
| 510k Number | K210362 |
| Device Name: | S-Clean Pre-Milled Abutment |
| 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 | 2021-02-08 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800053008983 | K210362 | 000 |
| 08800053008846 | K210362 | 000 |
| 08800053008853 | K210362 | 000 |
| 08800053008860 | K210362 | 000 |
| 08800053008877 | K210362 | 000 |
| 08800053008884 | K210362 | 000 |
| 08800053008891 | K210362 | 000 |
| 08800053008907 | K210362 | 000 |
| 08800053008914 | K210362 | 000 |
| 08800053008921 | K210362 | 000 |
| 08800053008938 | K210362 | 000 |
| 08800053008945 | K210362 | 000 |
| 08800053008952 | K210362 | 000 |
| 08800053008969 | K210362 | 000 |
| 08800053008976 | K210362 | 000 |
| 08800053008839 | K210362 | 000 |