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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K260682
Device Name Bond-PR™ Universal Adhesive
Applicant
Premier Dental Products Company
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Applicant Contact Jessica Huang
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received03/02/2026
Decision Date 03/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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