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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K260569
Device Name DB 4000 High Impact Denture Base
Applicant
Carbon, Inc.
1272 Borregas Ave.
Sunnyvale,  CA  94089
Applicant Contact Gina Policastro
Correspondent
Nilo Medical Consulting Group, LLC
3706 Butler St.
Suite #313
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/19/2026
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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