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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K923780
Device Name DENTOOL
Applicant
Dentool, Inc.
1200 Summit Ave.
Suite 518
Fort Worth,  TX  76102
Applicant Contact GLORIA REEVES
Correspondent
Dentool, Inc.
1200 Summit Ave.
Suite 518
Fort Worth,  TX  76102
Correspondent Contact GLORIA REEVES
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/28/1992
Decision Date 03/21/1995
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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