The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Tapered Ii Rbm Implant System.
| Device ID | K160213 |
| 510k Number | K160213 |
| Device Name: | S-Clean Tapered II RBM Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR 42718 |
| Contact | Sun Chul 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 | 2016-01-29 |
| Decision Date | 2016-06-21 |
| Summary: | summary |