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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K900342
Device Name UNITY DENTAL CEMENT
Applicant
Whaledent Intl. Div. Ipco
Consultant
36 Maplewood Rd.
Hartsdale,  NY  10530
Applicant Contact LEONARD WOLFSON
Correspondent
Whaledent Intl. Div. Ipco
Consultant
36 Maplewood Rd.
Hartsdale,  NY  10530
Correspondent Contact LEONARD WOLFSON
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/23/1990
Decision Date 05/07/1990
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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