← Product Code [EFB](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB) · K983183

# GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P (K983183)

_Bien Air USA, Inc. · EFB · Dec 10, 1998 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K983183

## Device Facts

- **Applicant:** Bien Air USA, Inc.
- **Product Code:** [EFB](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB.md)
- **Decision Date:** Dec 10, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4200
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K983183](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K983183)

**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