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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 K894315
Device Name RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
Applicant
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Applicant Contact TEIGLER, PH.D.
Correspondent
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Correspondent Contact TEIGLER, PH.D.
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/14/1989
Decision Date 10/31/1989
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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