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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression Tray, Resin
510(k) Number K890712
Device Name ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS
Applicant
Advantage Dental Products, Inc.
3051 E. Pontiac Rd.
P.O. Box 214767
Auburn Hills,  MI  48057
Applicant Contact JOSEPH J PELERIN
Correspondent
Advantage Dental Products, Inc.
3051 E. Pontiac Rd.
P.O. Box 214767
Auburn Hills,  MI  48057
Correspondent Contact JOSEPH J PELERIN
Regulation Number872.3670
Classification Product Code
EBH  
Date Received02/13/1989
Decision Date 04/25/1989
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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