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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name agent, tooth bonding, resin
510(k) Number K760400
Device Name BONDING AGENT, VYTOL
Applicant
L.D. CAULK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
L.D. CAULK CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/06/1976
Decision Date 08/23/1976
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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