Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K160979 |
Device Name |
Inclusive Abutments |
Applicant |
PRISMATIK DENTALCRAFT, INC. |
2212 DUPONT DRIVE, SUITE P |
IRVINE,
CA
92612
|
|
Applicant Contact |
SHELLY HARRIS |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL, SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA K. SCHULZ |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 04/07/2016 |
Decision Date | 11/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|