Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K212628 |
Device Name |
DESS Dental Smart Solutions |
Applicant |
Terrats Medical SL |
Carrer Mogoda 75-99 |
Barberá del Vallés,
ES
08210
|
|
Applicant Contact |
Roger Terrats |
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 | 08/19/2021 |
Decision Date | 03/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|