The following data is part of a premarket notification filed by J Dental Care S.r.l. with the FDA for Jdentalcare Implant System Jdicon.
| Device ID | K182081 |
| 510k Number | K182081 |
| Device Name: | JDentalCare Implant System JDIcon |
| Classification | Implant, Endosseous, Root-form |
| Applicant | J Dental Care S.r.l. via Del Tirassengno 41/N Modena, IT 41122 |
| Contact | Giacomo Grandi |
| Correspondent | Guido Gonapace Isemed Srl Via Palmiro Togliatti 19/X Imola, IT 40026 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2020-06-26 |