HOLD-FAST DENTURE ADHESIVE

Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-oxide Homopolymer

IODENT, CO.

The following data is part of a premarket notification filed by Iodent, Co. with the FDA for Hold-fast Denture Adhesive.

Pre-market Notification Details

Device IDK884999
510k NumberK884999
Device Name:HOLD-FAST DENTURE ADHESIVE
ClassificationAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-oxide Homopolymer
Applicant IODENT, CO. 1817 S. NEIL STREET, STE. B Champaign,  IL  61820
ContactFlorence M Nacino
CorrespondentFlorence M Nacino
IODENT, CO. 1817 S. NEIL STREET, STE. B Champaign,  IL  61820
Product CodeKOL  
CFR Regulation Number872.3410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-01
Decision Date1989-02-24

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