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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K090817
Device Name IONOLUX
Applicant
VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN,  DE D-27472
Applicant Contact M.TH. PLAUMANN
Correspondent
VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN,  DE D-27472
Correspondent Contact M.TH. PLAUMANN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/25/2009
Decision Date 07/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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