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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 K061998
Device Name PREMIER SELF-ETCHING BOND ENHANCER
Applicant
Premier Dental Products Co.
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Applicant Contact VINCE D'ALESSANDRO
Correspondent
Premier Dental Products Co.
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Correspondent Contact VINCE D'ALESSANDRO
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/14/2006
Decision Date 10/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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