Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K222604 |
Device Name |
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S |
Applicant |
dentona AG |
Otto-Hahn-Strasse 27 |
Dortmund,
DE
44227
|
|
Applicant Contact |
Andreas Foerster |
Correspondent |
APF Consulting |
Kleikstrasse 78 |
Herzogenrath,
DE
52134
|
|
Correspondent Contact |
Andreas Foerster |
Classification Product Code |
|
Date Received | 08/29/2022 |
Decision Date | 04/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|