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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K170375
Device Name Nobilplast Denture Resin
Applicant
Cmp Industries, LLC
413 N. Pearl St.
Albany,  NY  12207
Applicant Contact Devon O. Howe
Correspondent
Cmp Industries, LLC
413 N. Pearl St.
Albany,  NY  12207
Correspondent Contact Devon O. Howe
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/07/2017
Decision Date 10/02/2017
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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