The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Sq-sl Implant System Regular.
| Device ID | K210132 |
| 510k Number | K210132 |
| Device Name: | S-Clean SQ-SL Implant System Regular |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800053022385 | K210132 | 000 |
| 08800053022408 | K210132 | 000 |
| 08800053022415 | K210132 | 000 |
| 08800053022422 | K210132 | 000 |
| 08800053022439 | K210132 | 000 |
| 08800053022446 | K210132 | 000 |
| 08800053022453 | K210132 | 000 |
| 08800053022460 | K210132 | 000 |
| 08800053022477 | K210132 | 000 |
| 08800053035163 | K210132 | 000 |
| 08800053022392 | K210132 | 000 |