The following data is part of a premarket notification filed by Jj Implants with the FDA for Jj Implant System.
| Device ID | K190552 |
| 510k Number | K190552 |
| Device Name: | JJ Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJ Implants IX /214A, Munipara, Kanjirapilly PO Chalakudy, IN 680721 |
| Contact | Jiju John |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-12-06 |