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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Periodontic
510(k) Number K070127
Device Name PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
Applicant
Kevin Vu, Dds
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Applicant Contact Glen Feye
Correspondent
Kevin Vu, Dds
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Correspondent Contact Glen Feye
Regulation Number872.4565
Classification Product Code
EMN  
Date Received01/16/2007
Decision Date 03/29/2007
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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