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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Retentive And Splinting, And Accessory Instruments
510(k) Number K895758
Device Name PLASTIC TOOTH REINFORCEMENT KIT
Applicant
Nanzee Dental Products
950 Taxville Rd.
York,  PA  17404
Applicant Contact ALBERT G MUNCHEL
Correspondent
Nanzee Dental Products
950 Taxville Rd.
York,  PA  17404
Correspondent Contact ALBERT G MUNCHEL
Regulation Number872.3740
Classification Product Code
EBL  
Date Received09/26/1989
Decision Date 12/20/1989
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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