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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 K161734
Device Name Vanguard Dental Unit
Applicant
Ritter Concept GmbH
Bahnhofstrabe 65
Zwonitz,  DE 208297
Applicant Contact WEN FANG
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/23/2016
Decision Date 12/09/2016
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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