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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 K896361
Device Name HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
Applicant
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact DONALD I GONSER
Correspondent
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact DONALD I GONSER
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/06/1989
Decision Date 02/02/1990
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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