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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K921713
Device Name DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT
Applicant
A and V Ent.
227 Colchester Ave.
Burlington,  VT  05401
Applicant Contact VICTOR L RATKUS
Correspondent
A and V Ent.
227 Colchester Ave.
Burlington,  VT  05401
Correspondent Contact VICTOR L RATKUS
Classification Product Code
KJJ  
Date Received04/07/1992
Decision Date 11/04/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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