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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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