The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Sq-sl Implant System Mini.
| Device ID | K202773 |
| 510k Number | K202773 |
| Device Name: | S-Clean SQ-SL Implant System Mini |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800053024518 | K202773 | 000 |
| 08800053023979 | K202773 | 000 |
| 08800053023962 | K202773 | 000 |
| 08800053023955 | K202773 | 000 |
| 08800053023948 | K202773 | 000 |
| 08800053023887 | K202773 | 000 |
| 08800053023870 | K202773 | 000 |
| 08800053023863 | K202773 | 000 |
| 08800053023856 | K202773 | 000 |
| 08800053023849 | K202773 | 000 |
| 08800053023832 | K202773 | 000 |
| 08800053023801 | K202773 | 000 |
| 08800053023795 | K202773 | 000 |
| 08800053023986 | K202773 | 000 |
| 08800053023993 | K202773 | 000 |
| 08800053024006 | K202773 | 000 |
| 08800053024501 | K202773 | 000 |
| 08800053024495 | K202773 | 000 |
| 08800053024471 | K202773 | 000 |
| 08800053024464 | K202773 | 000 |
| 08800053024457 | K202773 | 000 |
| 08800053024150 | K202773 | 000 |
| 08800053024143 | K202773 | 000 |
| 08800053024136 | K202773 | 000 |
| 08800053024112 | K202773 | 000 |
| 08800053024105 | K202773 | 000 |
| 08800053024099 | K202773 | 000 |
| 08800053024013 | K202773 | 000 |
| 08800053023733 | K202773 | 000 |