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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 K863831
Device Name VIVADENT FILPIN
Applicant
Vivadent (Usa), Inc.
182 Wales St.
P.O. Box 304
Tonawanda,  NY  14150
Applicant Contact GEORGE W TYSOWSKY
Correspondent
Vivadent (Usa), Inc.
182 Wales St.
P.O. Box 304
Tonawanda,  NY  14150
Correspondent Contact GEORGE W TYSOWSKY
Regulation Number872.3740
Classification Product Code
EBL  
Date Received09/30/1986
Decision Date 10/14/1986
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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