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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K042822
Device Name TCM ENDO V, MODEL 1534
Applicant
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH 5412
Applicant Contact ERICH FORSTER
Correspondent
NOUVAG AG
Reusswehrstrasse 1
Gebenstorf,  CH 5412
Correspondent Contact ERICH FORSTER
Regulation Number872.4200
Classification Product Code
EKX  
Date Received10/12/2004
Decision Date 12/22/2004
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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