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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K261987
Device Name Reusable SmartPeg
Applicant
Osstell AB
Stampgaten 14
Goteborg,  SE SE 411-01
Applicant Contact Stellan Sundstroem
Correspondent
ProPharma Group
1129 20th St. NW
Suite 600
Washington,  DC  20036
Correspondent Contact Cherita James
Regulation Number872.4200
Classification Product Code
EKX  
Date Received06/12/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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