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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthpiece, Saliva Ejector
510(k) Number K940769
Device Name DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR
Applicant
Terraflex
P.O. Box 1310
Efrat 90962,  IL
Applicant Contact ELI M ORBACH
Correspondent
Terraflex
P.O. Box 1310
Efrat 90962,  IL
Correspondent Contact ELI M ORBACH
Regulation Number872.6640
Classification Product Code
DYN  
Date Received02/18/1994
Decision Date 08/17/1994
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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