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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 K911506
Device Name MODEL 2100 PORTABLE FIELD UNIT
Applicant
Dntl Corp.
12742 E. Caley Ave.
Englewood,  CO  80111
Applicant Contact BOB GIVAN
Correspondent
Dntl Corp.
12742 E. Caley Ave.
Englewood,  CO  80111
Correspondent Contact BOB GIVAN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/04/1991
Decision Date 06/24/1991
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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