The following data is part of a premarket notification filed by J Dental Care S.r.l with the FDA for Jdentalcare Implant System.
| Device ID | K143142 |
| 510k Number | K143142 |
| Device Name: | JDENTALCARE Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | J DENTAL CARE S.r.l Via Del Tirassegno 41/N Modena, IT 41122 |
| Contact | Giacomo Grandi |
| Correspondent | Maurizio Pantaleoni ISEMED Srl via A. BONETTI 3/A 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 | 2014-11-03 |
| Decision Date | 2015-11-06 |
| Summary: | summary |