The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Tin Coating Abutments.
| Device ID | K171694 |
| 510k Number | K171694 |
| Device Name: | S-Clean TiN Coating Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-07 |
| Decision Date | 2017-11-29 |
| Summary: | summary |