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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K181965
FOIA Releasable 510(k) K181965
Device Name Restore Toothpaste
Applicant
Dr. Collins, Inc.
4330 Barranca Pkwy. Suite #100
Irvine,  CA  92604
Applicant Contact Jiahe Li
Correspondent
Dr. Collins, Inc.
4330 Barranca Pkwy. Suite #100
Irvine,  CA  92604
Correspondent Contact Jiahe Li
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/23/2018
Decision Date 06/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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