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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Beam, X-Ray
510(k) Number K891186
Device Name REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
Applicant
Benn Research , Ltd.
2 Pangbourne Dr.
Stanmore, Middlesex,  GB HA7 4QT
Applicant Contact DOUGLAS K BENN
Correspondent
Benn Research , Ltd.
2 Pangbourne Dr.
Stanmore, Middlesex,  GB HA7 4QT
Correspondent Contact DOUGLAS K BENN
Regulation Number872.1820
Classification Product Code
EHA  
Date Received03/06/1989
Decision Date 04/12/1989
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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