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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K874189
Device Name DUAL-CURE RADIOPAQUE
Applicant
Pentron Corp.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Applicant Contact MARTIN L SCHULMAN
Correspondent
Pentron Corp.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Correspondent Contact MARTIN L SCHULMAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/14/1987
Decision Date 02/11/1988
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
Recalls CDRH Recalls
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