← Product Code [KOP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOP) · K802285

# OHIO THORACIC SUCTION REGULATOR (K802285)

_Ohio Medical Products · KOP · Oct 3, 1980 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOP/K802285

## Device Facts

- **Applicant:** Ohio Medical Products
- **Product Code:** [KOP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOP.md)
- **Decision Date:** Oct 3, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3450
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya 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/KOP/K802285](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOP/K802285)

**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:** Innolitics at https://innolitics.com