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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Maintainer, Space Preformed, Orthodontic
510(k) Number K864376
Device Name FIBERBOND
Applicant
Dentec, Inc.
P.O. Box 296
Roslyn,  NY  11576
Correspondent
Dentec, Inc.
P.O. Box 296
Roslyn,  NY  11576
Regulation Number872.5525
Classification Product Code
DYT  
Date Received11/05/1986
Decision Date 04/07/1987
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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