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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 K180463
Device Name Apoller Flow Light Cure Flowable Composite
Applicant
Greenway Yw, LLC
21 N. Skokie Hwy., Suite 204
Lake Bluff,  IL  60044
Applicant Contact Scott Yin
Correspondent
Iris Global, LLC
40931 W. Hopper Dr.
Maricopa,  AZ  85138
Correspondent Contact Maritza Moncayo
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/21/2018
Decision Date 11/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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