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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K760783
Device Name BIOBOND-CROWN & BRIDGE CERAMIC BONDING
Applicant
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dentsply Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3060
Classification Product Code
EJS  
Date Received10/05/1976
Decision Date 10/15/1976
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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