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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Resin
510(k) Number K770160
Device Name CERAMIST BRUSH
Applicant
DERINGER-NEY INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DERINGER-NEY INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3140
Classification Product Code
KXR  
Date Received01/24/1977
Decision Date 01/31/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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