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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K994302
Device Name RESIN TOOTH BONDING AGENT
Applicant
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Applicant Contact NELSON J GENDUSA
Correspondent
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Correspondent Contact NELSON J GENDUSA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/21/1999
Decision Date 02/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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