Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K212394 |
Device Name |
Implant-One Multi-Unit Abutment |
Applicant |
Implant Logistics, Inc. |
711 Spartan Drive |
Sparta,
WI
54656
|
|
Applicant Contact |
Thomas Arendt |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Floyd G. Larson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 08/02/2021 |
Decision Date | 03/23/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|