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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K883418
Device Name DE-BOND 200
Applicant
Scheu-Dental
One Farragut Sq. S., NW
Washington,  DC  20006
Applicant Contact LOTHAR GRIESSBACH
Correspondent
Scheu-Dental
One Farragut Sq. S., NW
Washington,  DC  20006
Correspondent Contact LOTHAR GRIESSBACH
Regulation Number872.4565
Classification Product Code
EKS  
Date Received08/15/1988
Decision Date 10/24/1989
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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