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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K250512
Device Name Augmented Gingival Matrix
Applicant
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Rm. 301,302, Bldg. 11, # 8 Jinfeng Rd.,
Suzhou New District
Suzhou,  CN 215163
Applicant Contact Jade Guo
Correspondent
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Rm. 301,302, Bldg. 11, # 8 Jinfeng Rd.,
Suzhou New District
Suzhou,  CN 215163
Correspondent Contact Jade Guo
Regulation Number872.3930
Classification Product Code
NPL  
Date Received02/21/2025
Decision Date 12/05/2025
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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