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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K192806
Device Name DENTCA Crown and Bridge
Applicant
Dentca, Inc.
357 Van Ness Way #250
Torrance,  CA  90501
Applicant Contact Jason Lee
Correspondent
The 510k Consulting, LLC
1449 Springleaf Dr.
Ormond Beach,  FL  32174
Correspondent Contact Joyce St. Germain
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/01/2019
Decision Date 02/05/2020
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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