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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K253758
Device Name Dental Cone; Dental Sponge
Applicant
Medizin Produkte Neustadt GmbH (Mpn)
Donaustrasse 24
Saal/Donau Bavaria,  DE 93342
Applicant Contact Danielle Lindner
Correspondent
Medizin Produkte Neustadt GmbH (Mpn)
Donaustrasse 24
Saal/Donau Bavaria,  DE 93342
Correspondent Contact Danielle Lindner
Classification Product Code
OLR  
Subsequent Product Code
KGN  
Date Received11/25/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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