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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K973492
Device Name DENTALVIEW PERIOVIEW SYSTEM
Applicant
Dentalview, Inc.
15540-D Rockfield Blvd.
Irvine,  CA  92618
Applicant Contact WENDELL EBLING
Correspondent
Dentalview, Inc.
15540-D Rockfield Blvd.
Irvine,  CA  92618
Correspondent Contact WENDELL EBLING
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/15/1997
Decision Date 10/21/1997
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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