Device Classification Name |
dental amalgam
|
510(k) Number |
K223182 |
Device Name |
Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy |
Applicant |
WorldWork S.R.L |
Via Del Progresso, 47 |
Montebello,
IT
36054
|
|
Applicant Contact |
Daniela Baldissera |
Correspondent |
WorldWork S.R.L |
Via Del Progresso, 47 |
Montebello,
IT
36054
|
|
Correspondent Contact |
Daniela Baldissera |
Regulation Number | 872.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/11/2022 |
Decision Date | 05/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|