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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 K864300
Device Name SILIVA EJECTOR/ORAL CAVITY EVACUATOR
Applicant
Ardent Intl., Inc.
165 Mansion Rd.
Newtown Square,  PA  19073
Applicant Contact B. N STAHLMAN
Correspondent
Ardent Intl., Inc.
165 Mansion Rd.
Newtown Square,  PA  19073
Correspondent Contact B. N STAHLMAN
Regulation Number872.6640
Classification Product Code
DYN  
Date Received10/31/1986
Decision Date 11/24/1986
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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