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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 K191656
Device Name Zipbond
Applicant
SDI Limited
3-15 Brunsdon Street
Bayswater,  AU 3153
Applicant Contact Ray Cahill
Correspondent
SDI Limited
3-15 Brunsdon Street
Bayswater,  AU 3153
Correspondent Contact Ray Cahill
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EMA  
Date Received06/21/2019
Decision Date 12/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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