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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
MQC  
Date Received08/29/2022
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
Predetermined Change
Control Plan Authorized		 No
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