The following data is part of a premarket notification filed by Ditron Precision Ltd with the FDA for Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments And Pr.
Device ID | K140728 |
510k Number | K140728 |
Device Name: | MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR |
Classification | Implant, Endosseous, Root-form |
Applicant | DITRON PRECISION LTD HAOFE 2ST., P.O. BOX 5010 Ashkelon, IL 78150 |
Contact | Tali Hazan |
Correspondent | Tali Hazan DITRON PRECISION LTD RAMOT NAFTALI M.P UPPER GALILLEE Ramot Naftali, IL 13830 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-24 |
Decision Date | 2014-10-17 |
Summary: | summary |