Device Classification Name |
laser, dental, soft tissue
|
510(k) Number |
K213658 |
Device Name |
DEKA SMARTPERIO |
Applicant |
El.En Electronic Engineering Spa |
Via Baldanzese 17 |
Calenzano,
FL
50041
|
|
Applicant Contact |
Paolo Peruzzi |
Correspondent |
El.En Electronic Engineering Spa |
Via Baldanzese 17 |
Calenzano,
FL
50041
|
|
Correspondent Contact |
Paolo Peruzzi |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2021 |
Decision Date | 03/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|