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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K011222
Device Name PORTABELL, MODEL 4200
Applicant
Bell Dental Products, LLC
3003 Arapahoe St., #101-B
Denver,  CO  80205
Applicant Contact DAN BELL
Correspondent
Bell Dental Products, LLC
3003 Arapahoe St., #101-B
Denver,  CO  80205
Correspondent Contact DAN BELL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/20/2001
Decision Date 06/25/2001
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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