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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 K002086
Device Name PRIMAFLOW
Applicant
DMG USA, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
DMG USA, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/10/2000
Decision Date 08/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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