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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K952333
Device Name PLASMA ARC CURING SYSTEM
Applicant
American Dental Technologies, Inc.
125 Shoreway Rd.
Suite 3000
San Carlos,  CA  94070
Applicant Contact MICHAEL YESSIK
Correspondent
American Dental Technologies, Inc.
125 Shoreway Rd.
Suite 3000
San Carlos,  CA  94070
Correspondent Contact MICHAEL YESSIK
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/18/1995
Decision Date 08/10/1995
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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