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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K260268
Device Name OrthoEasy Pal; OrthoEasy Pal Long Neck
Applicant
Bernhard Förster GmbH (Bernhard Foerster Ltd.)
Westliche Karl-Friedrich-Strasse 151
Pforzheim,  DE 75172
Applicant Contact Stefan Förster
Correspondent
Compliance 4 Devices, Ltd.
118 Prive Cir.
Delray Beach,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number872.3640
Classification Product Code
OAT  
Subsequent Product Code
DYJ  
Date Received01/28/2026
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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