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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K251701
Device Name Star E900 Electric System
Applicant
Dentalez, Inc., Stardental Division
1816 Colonial Village Lane
Lancaster,  PA  17601
Applicant Contact Robert Young
Correspondent
Dentalez, Inc., Stardental Division
1816 Colonial Village Lane
Lancaster,  PA  17601
Correspondent Contact Kay Engle
Regulation Number872.4200
Classification Product Code
EBW  
Date Received06/02/2025
Decision Date 01/12/2026
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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