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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K211396
Device Name Neoss Individual Prosthetics
Neoss Ltd
Windsor House Cornwell Road
Harrogate,  GB HG1 2PW
Applicant Contact Stellan Sundstrom
M Squared Associates Inc.
127 West 30th Street, Floor 9
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number872.3630
Classification Product Code
Date Received05/05/2021
Decision Date 05/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No