The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Well-root St.
| Device ID | K170950 |
| 510k Number | K170950 |
| Device Name: | Well-Root ST |
| Classification | Resin, Root Canal Filling |
| Applicant | Vericom Co., Ltd. 48, Toegyegongdan 1-Gil, Chuncheon-si, KR 200-944 |
| Contact | Hyoshin Chung |
| Correspondent | Priscilla Chung Lk Consulting Group USA, Inc 690 Roosevelt Irvine, CA 92620 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-12-20 |
| Summary: | summary |