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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Alloy, Other Noble Metal
510(k) Number K972533
Device Name VERA SOLDER
Applicant
Aalba Dent, Inc.
400 Watt Dr.
Fairfield,  CA  94534
Applicant Contact VINCENT M BENETTI
Correspondent
Aalba Dent, Inc.
400 Watt Dr.
Fairfield,  CA  94534
Correspondent Contact VINCENT M BENETTI
Regulation Number872.3060
Classification Product Code
EJS  
Date Received07/07/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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