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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K092446
Device Name INTRA LUX HEAD 3 LDSY
Applicant
Kaltenbach & Voigt GmbH & Co.
1717 W. Collins
Orange,  CA  92867
Applicant Contact CLAUDIA ORTIZ
Correspondent
Kaltenbach & Voigt GmbH & Co.
1717 W. Collins
Orange,  CA  92867
Correspondent Contact CLAUDIA ORTIZ
Regulation Number872.4200
Classification Product Code
EFA  
Date Received08/10/2009
Decision Date 11/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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