The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for Oneq-sl S-clean Implant System.
| Device ID | K170220 |
| 510k Number | K170220 |
| Device Name: | OneQ-SL S-Clean Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTIS CO., LTD. 99, SEONGSEOSEO-RO, DALSEO-GU Daegu, KR 42718 |
| Contact | Sun Chu Shin |
| Correspondent | April Lee WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights, CA 91748 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806169146571 | K170220 | 000 |
| 08806169134592 | K170220 | 000 |
| 08806169134608 | K170220 | 000 |
| 08806169134615 | K170220 | 000 |
| 08806169134622 | K170220 | 000 |
| 08806169134639 | K170220 | 000 |
| 08806169134684 | K170220 | 000 |
| 08806169134745 | K170220 | 000 |
| 08806169134806 | K170220 | 000 |
| 08806169134585 | K170220 | 000 |
| 08806169127136 | K170220 | 000 |
| 08800053008365 | K170220 | 000 |
| 08800053008372 | K170220 | 000 |
| 08800053008389 | K170220 | 000 |
| 08800053008396 | K170220 | 000 |
| 08806169127099 | K170220 | 000 |
| 08806169127105 | K170220 | 000 |
| 08806169127112 | K170220 | 000 |
| 08806169127129 | K170220 | 000 |
| 08806169135438 | K170220 | 000 |
| 08806169127471 | K170220 | 000 |
| 08806169127853 | K170220 | 000 |
| 08806169127860 | K170220 | 000 |
| 08806169127877 | K170220 | 000 |
| 08806169127884 | K170220 | 000 |
| 08806169146533 | K170220 | 000 |
| 08806169146540 | K170220 | 000 |
| 08806169146557 | K170220 | 000 |
| 08806169146564 | K170220 | 000 |
| 08806169127846 | K170220 | 000 |
| 08806169127839 | K170220 | 000 |
| 08806169127488 | K170220 | 000 |
| 08806169127495 | K170220 | 000 |
| 08806169127501 | K170220 | 000 |
| 08806169127518 | K170220 | 000 |
| 08806169127792 | K170220 | 000 |
| 08806169127808 | K170220 | 000 |
| 08806169127815 | K170220 | 000 |
| 08806169127822 | K170220 | 000 |
| 08800053008358 | K170220 | 000 |