← Product Code [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD) · K771901

# CAPMIX (K771901)

_Espe Dental Products · EFD · Oct 20, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K771901

## Device Facts

- **Applicant:** Espe Dental Products
- **Product Code:** [EFD](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD.md)
- **Decision Date:** Oct 20, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3100
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K771901](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFD/K771901)

**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