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 |