The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Dentium Ti-base.
| Device ID | K171622 |
| 510k Number | K171622 |
| Device Name: | Dentium Ti-Base |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentium Co., Ltd. 150, Eondong-ro Giheung-gu Yongin-si, KR 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 | 2017-06-02 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809544905978 | K171622 | 000 |
| 08809544904940 | K171622 | 000 |
| 08809544904957 | K171622 | 000 |
| 08809544904964 | K171622 | 000 |
| 08809544904971 | K171622 | 000 |
| 08809544904988 | K171622 | 000 |
| 08809544904995 | K171622 | 000 |
| 08809544905008 | K171622 | 000 |
| 08809544905947 | K171622 | 000 |
| 08809544905954 | K171622 | 000 |
| 08809544905961 | K171622 | 000 |
| 08809544904933 | K171622 | 000 |