← Product Code [EBD](/productcode/EBD) · K904135

# FOUNDATION HYBRID COMPOSITE (K904135)

_Nulite Systems Research · EBD · May 15, 1991 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K904135

## Device Facts

- **Applicant:** Nulite Systems Research
- **Product Code:** [EBD](/productcode/EBD.md)
- **Decision Date:** May 15, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3310
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

---

**Source:** [https://fda-staging.innolitics.com/device/K904135](https://fda-staging.innolitics.com/device/K904135)

**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