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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 K260430
Device Name Porcelain Etch Gel
Applicant
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Jingtian Peng
Correspondent
Belport Company, Inc., Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Jingtian Peng
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/10/2026
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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