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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name activator, ultraviolet, for polymerization
510(k) Number K210550
Device Name VALO Grand Corded and Accessory Lenses
Applicant
Ultradent Products, Inc
505 West Ultradent Drive (10200 South)
South Jordan,  UT  84095
Applicant Contact Adam Black
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.6070
Classification Product Code
EBZ  
Subsequent Product Codes
EAQ   PEQ  
Date Received02/25/2021
Decision Date 03/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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