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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
510(k) Number K884999
Device Name HOLD-FAST DENTURE ADHESIVE
Applicant
IODENT, CO.
1817 S. NEIL STREET, STE. B
CHAMPAIGN,  IL  61820
Applicant Contact FLORENCE M NACINO
Correspondent
IODENT, CO.
1817 S. NEIL STREET, STE. B
CHAMPAIGN,  IL  61820
Correspondent Contact FLORENCE M NACINO
Regulation Number872.3410
Classification Product Code
KOL  
Date Received12/01/1988
Decision Date 02/24/1989
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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