The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for U-cem Premium & Mazic Cem.
| Device ID | K193260 |
| 510k Number | K193260 |
| Device Name: | U-Cem Premium & MAZIC Cem |
| Classification | Cement, Dental |
| Applicant | Vericom Co., Ltd. 48, Toegyegongdan 1-Gil, Chuncheon-si, KR 200-944 |
| Contact | Yun Ki Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-08-21 |