The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Dentium Nr Line Cad/cam Abutments.
| Device ID | K170384 |
| 510k Number | K170384 |
| Device Name: | Dentium NR Line CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 16985 |
| Contact | Sangpil Yoon |
| Correspondent | Sangpil Yoon Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 16985 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809162709248 | K170384 | 000 |
| 08809162709132 | K170384 | 000 |
| 08809162709125 | K170384 | 000 |
| 08809162709118 | K170384 | 000 |
| 08809162709101 | K170384 | 000 |
| 08809162709095 | K170384 | 000 |
| 08809162709088 | K170384 | 000 |
| 08809162709071 | K170384 | 000 |
| 08809544901840 | K170384 | 000 |
| 08809162709149 | K170384 | 000 |
| 08809162709156 | K170384 | 000 |
| 08809162709231 | K170384 | 000 |
| 08809162709224 | K170384 | 000 |
| 08809162709217 | K170384 | 000 |
| 08809162709200 | K170384 | 000 |
| 08809162709194 | K170384 | 000 |
| 08809162709187 | K170384 | 000 |
| 08809162709170 | K170384 | 000 |
| 08809162709163 | K170384 | 000 |
| 08809162708821 | K170384 | 000 |