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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Barriers And Sleeves
510(k) Number K262073
Device Name Hygienic Protective Bite Cover (2207-010-50)
Applicant
Dürr Dental SE
Höpfigheimer St. 17
Bietigheim-Bissingen,  DE 74321
Applicant Contact Oliver Lange
Correspondent
Dürr Dental SE
Höpfigheimer St. 17
Bietigheim-Bissingen,  DE 74321
Correspondent Contact Corinna Gordillo
Regulation Number878.4370
Classification Product Code
PEM  
Date Received06/22/2026
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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