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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K122974
Device Name TRYOUT-VPS HOLDING PASTE
Applicant
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Applicant Contact MARK KONOPKA
Correspondent
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Correspondent Contact MARK KONOPKA
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/26/2012
Decision Date 05/17/2013
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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