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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K000894
Device Name C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO
Applicant
Dental Ventures of America, Inc.
217 Lewis Ct.
Corona,  CA  91720
Applicant Contact ANTHONY SIRAGUSA
Correspondent
Dental Ventures of America, Inc.
217 Lewis Ct.
Corona,  CA  91720
Correspondent Contact ANTHONY SIRAGUSA
Regulation Number872.3770
Classification Product Code
EBG  
Date Received03/20/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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