Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K220612 |
Device Name |
PrimeLOC Attachment System |
Applicant |
Innovative Product Brands, Inc. |
7045 Palm Avenue |
Highland,
CA
92346
|
|
Applicant Contact |
Chris Gervais |
Correspondent |
PaxMed International, LLC |
12264 EL Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/03/2022 |
Decision Date | 06/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|