Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K143515 |
Device Name |
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants |
Applicant |
PRISMATIK DENTALCRAFT, INC. |
2212 Dupont Dr., Suite P |
Irvine,
CA
92612
|
|
Applicant Contact |
Brandon Shepard |
Correspondent |
PRISMATIK DENTALCRAFT, INC. |
2212 Dupont Dr., Suite P |
Irvine,
CA
92612
|
|
Correspondent Contact |
Brandon Shepard |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/11/2014 |
Decision Date | 10/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|