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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 St.
Bayswater,  AU 3153
Applicant Contact Ray Cahill
Correspondent
Sdi Limited
3-15 Brunsdon St.
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
Predetermined Change
Control Plan Authorized		 No
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