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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 K924670
Device Name DENTIN RELIEF
Applicant
Professional Technologies Corp.
518 Dryden Rd., Suite A1h
Ithaca,  NY  14850
Applicant Contact VAJIH KHAN
Correspondent
Professional Technologies Corp.
518 Dryden Rd., Suite A1h
Ithaca,  NY  14850
Correspondent Contact VAJIH KHAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/16/1992
Decision Date 11/23/1992
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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