The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Implantium Ii.
| Device ID | K171126 |
| 510k Number | K171126 |
| Device Name: | Implantium II |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Dentium Co., Ltd. 150, Eondong-ro Giheung-gu Yongin-si, KR 443-270 |
| Contact | Yoon Spyoon |
| Correspondent | Joyce St. Germain Denterprise International, Inc. / 510k FDA Consulting 100 East Granada Bldv, Suite 219 Ormond Beach, FL 32176 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809544904889 | K171126 | 000 |
| 08809544904742 | K171126 | 000 |
| 08809544904759 | K171126 | 000 |
| 08809544904766 | K171126 | 000 |
| 08809544904773 | K171126 | 000 |
| 08809544904780 | K171126 | 000 |
| 08809544904797 | K171126 | 000 |
| 08809544904803 | K171126 | 000 |
| 08809544904810 | K171126 | 000 |
| 08809544904827 | K171126 | 000 |
| 08809544904834 | K171126 | 000 |
| 08809544904841 | K171126 | 000 |
| 08809544904858 | K171126 | 000 |
| 08809544904865 | K171126 | 000 |
| 08809544904872 | K171126 | 000 |
| 08809544904735 | K171126 | 000 |