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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
Applicant
Neoss Ltd
Windsor House Cornwell Road
Harrogate,  GB HG1 2PW
Applicant Contact Stellan Sundstrom
Correspondent
M Squared Associates Inc.
127 West 30th Street, Floor 9
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number872.3630
Classification Product Code
NHA  
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
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