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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture Repair Kit
510(k) Number K844480
Device Name DENTAL ORAL CARE SYSTEMS & COMPONENTS
Applicant
Advanced Bio Systems, Inc.
80 E. Hawthorne Ave.
Valley Stream,  NY  11580
Applicant Contact TRACEY PRAT
Correspondent
Advanced Bio Systems, Inc.
80 E. Hawthorne Ave.
Valley Stream,  NY  11580
Correspondent Contact TRACEY PRAT
Regulation Number872.3570
Classification Product Code
EBO  
Date Received11/19/1984
Decision Date 06/19/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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