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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plaque disclosing agent
510(k) Number K770990
Device Name DENTAL PLAQUE DISCLOSING AGENT
Applicant
EVIDENT DENTAL CO. LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EVIDENT DENTAL CO. LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.6855
Classification Product Code
QJC  
Date Received05/31/1977
Decision Date 06/20/1977
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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