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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K902115
Device Name PALAPRESS(R) VARIO RESIN
Applicant
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Kulzer, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received05/10/1990
Decision Date 07/27/1990
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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