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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K850915
Device Name WAX BITE IMPRESSION WAFER
Applicant
Toothprints, Inc.
232 Pond St.
Natick,  MA  01760
Applicant Contact DAVID A TESINI
Correspondent
Toothprints, Inc.
232 Pond St.
Natick,  MA  01760
Correspondent Contact DAVID A TESINI
Regulation Number872.6890
Classification Product Code
EGD  
Date Received03/05/1985
Decision Date 04/16/1985
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
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