Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K140728 |
Device Name |
MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR |
Applicant |
DITRON PRECISION LTD |
HAOFE 2ST., P.O. BOX 5010 |
ASHKELON,
IL
78150
|
|
Applicant Contact |
TALI HAZAN |
Correspondent |
DITRON PRECISION LTD |
RAMOT NAFTALI |
M.P UPPER GALILLEE |
RAMOT NAFTALI,
IL
13830
|
|
Correspondent Contact |
TALI HAZAN |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2014 |
Decision Date | 10/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|