The following data is part of a premarket notification filed by Dentalis Bio Solution Implants Llc with the FDA for Dentalis Bio Solution Implants.
| Device ID | K161281 |
| 510k Number | K161281 |
| Device Name: | Dentalis Bio Solution Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTALIS BIO SOLUTION IMPLANTS LLC 2801 FORTUNE CIRCLE E, SUITE B Indianapolis, IN 46241 |
| Contact | Osnat Yanai |
| Correspondent | Jacob Azulay DENTALIS BIO SOLUTION IMPLANTS LLC 2801 FORTUNE CIRCLE E, SUITE B Indianapolis, IN 46241 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2017-01-11 |