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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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