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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K243094
Device Name Quickdent Dental Implant System
Applicant
Quickdent Devices Private Ltd.
Unit No. 128, Kuber Complex New Link Rd S N of Village
Oshwari Link Rd, Adheri
West, Mumbai, Mumbai Surburban,  IN 400053
Applicant Contact Mayur Khairnar
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/30/2024
Decision Date 12/19/2024
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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