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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 K931204
Device Name AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)
Applicant
Den-Tal-Ez Mfg Co., Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM LAMBERTSON
Correspondent
Den-Tal-Ez Mfg Co., Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM LAMBERTSON
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/09/1993
Decision Date 07/08/1993
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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