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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 K234043
Device Name 3M™ Transbond™ Orthodontic Adhesive
Applicant
3M Unitek Orthodontic Products
2724 South Peck Rd.
Monrovia,  CA  91016
Applicant Contact Chandrapaul Parsram
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 Received12/21/2023
Decision Date 12/22/2023
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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