← Product Code [KOT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT) · K895818 # STEADFAST DENTURE ADHESIVE CREAM (K895818) _Stiefel Research Institute, Inc. · KOT · Apr 3, 1990 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K895818 ## Device Facts - **Applicant:** Stiefel Research Institute, Inc. - **Product Code:** [KOT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT.md) - **Decision Date:** Apr 3, 1990 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3490 - **Device Class:** Class 1 - **Review Panel:** Dental ## Regulatory Identification A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K895818](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K895818) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K895818