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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K864404
Device Name PENTRON HIGH STRENGTH PORCELAIN
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 Number872.6660
Classification Product Code
EIH  
Date Received11/10/1986
Decision Date 11/24/1986
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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