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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K211212
Device Name LoFric Elle
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Rebecca Sporer
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Rebecca Sporer
Regulation Number876.5130
Classification Product Code
EZD  
Date Received04/23/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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