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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K251946
Device Name G aenial Universal Injectable II
Applicant
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact Futoshi Fusejima
Correspondent
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Correspondent Contact Futoshi Fusejima
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
DYH   EBC   EMA  
Date Received06/25/2025
Decision Date 08/29/2025
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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