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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K790325
Device Name REPRODENT
Applicant
Premier Dental Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Premier Dental Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/15/1979
Decision Date 03/02/1979
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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