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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Impression, Preformed
510(k) Number K884316
Device Name OCCLUSAL HARMONY IMPRESSION TRAY
Applicant
Advantage Dental Co.
3051 E. Pontiac Rd.
Auburn Hills,  MI  48057
Applicant Contact J PELERIN,DDS
Correspondent
Advantage Dental Co.
3051 E. Pontiac Rd.
Auburn Hills,  MI  48057
Correspondent Contact J PELERIN,DDS
Regulation Number872.6880
Classification Product Code
EHY  
Date Received10/13/1988
Decision Date 12/22/1988
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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