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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K250015
Device Name Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
Applicant
Ormco Corporation
200 S Kraemer Blvd
Brea,  CA  92821
Applicant Contact Tara Bonny
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3750
Classification Product Code
DYH  
Date Received01/02/2025
Decision Date 01/03/2025
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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