← Product Code [KHR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KHR) · K780400

# DEN-Z-ORB (K780400)

_Nice-Pak Products, Inc. · KHR · Mar 27, 1978 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KHR/K780400

## Device Facts

- **Applicant:** Nice-Pak Products, Inc.
- **Product Code:** [KHR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KHR.md)
- **Decision Date:** Mar 27, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6050
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KHR/K780400](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KHR/K780400)

**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