Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K191919 |
Device Name |
Elos Accurate Hybrid Base |
Applicant |
Elos Medtech Pinol A/S |
Engvej 33 |
gorlose,
DK
dk-3330
|
|
Applicant Contact |
tina friis poulsen |
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 | 07/18/2019 |
Decision Date | 02/10/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|