The following data is part of a premarket notification filed by Dentium Co., Ltd with the FDA for Dentium Cad/cam Abutments.
| Device ID | K161713 |
| 510k Number | K161713 |
| Device Name: | Dentium CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentium Co., Ltd 150, Eondong-ro, Giheung-gu Yongin-si, KP 443-270 |
| Contact | Sangpil Yoon |
| Correspondent | Linda K. Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2016-12-16 |
| Summary: | summary |