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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K001041
Device Name AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
Applicant
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Applicant Contact GERHARD POLZER
Correspondent
Wieland Edelmetalle GmbH & Co.
Schwenninger Strabe 13
Pforzheim,  DE D-75179
Correspondent Contact GERHARD POLZER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/31/2000
Decision Date 05/23/2000
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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