← Product Code [EBP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP) · K790589

# DENTURE-TIGHT (K790589)

_Den-Mat Corp. · EBP · Aug 10, 1979 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K790589

## Device Facts

- **Applicant:** Den-Mat Corp.
- **Product Code:** [EBP](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP.md)
- **Decision Date:** Aug 10, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3560
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K790589](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K790589)

**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