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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K191548
Device Name Nexus Universal Self-Cure
Applicant
Kerr Corporation
1717 W. Collins Ave
orange,  CA  92867
Applicant Contact ardrena jackson
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
orange,  CA  92867
Correspondent Contact ardrena jackson
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/12/2019
Decision Date 10/11/2019
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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