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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K923674
Device Name DENSPRO COARSE MINT PROPHY PASTE
Applicant
Teledyne Getz
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Applicant Contact RIEL LEBOVIC
Correspondent
Teledyne Getz
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Correspondent Contact RIEL LEBOVIC
Regulation Number872.6030
Classification Product Code
EJR  
Date Received07/22/1992
Decision Date 11/05/1992
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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