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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K904289
Device Name PERTAC UNIVERSAL BOND
Applicant
ESPE GMBH (US)
200 LAKE AVENUE (#205)
LAKE WORTH,  FL  33460
Applicant Contact HAROLD A OPOTOW
Correspondent
ESPE GMBH (US)
200 LAKE AVENUE (#205)
LAKE WORTH,  FL  33460
Correspondent Contact HAROLD A OPOTOW
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/17/1990
Decision Date 11/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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