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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K892710
Device Name ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)
Applicant
Prometex, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Applicant Contact M BUTTERLIN
Correspondent
Prometex, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Correspondent Contact M BUTTERLIN
Regulation Number872.3770
Classification Product Code
EBG  
Date Received04/14/1989
Decision Date 10/24/1989
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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