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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 K884588
Device Name HELIOMOLAR(R) DENTAL RESTORATIVE
Applicant
WILLIAMS DENTAL CO., INC.
2948 MAIN ST.
BUFFALO,  NY  14214
Applicant Contact GARY L SEVERANCE
Correspondent
WILLIAMS DENTAL CO., INC.
2948 MAIN ST.
BUFFALO,  NY  14214
Correspondent Contact GARY L SEVERANCE
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/02/1988
Decision Date 01/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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