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 |