← Product Code [EBW](/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW) · K770129

# SPRINT S-2 INSTRU. CENTER (MODEL 92329) (K770129)

_Chemetron Health Systems · EBW · Jan 28, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K770129

## Device Facts

- **Applicant:** Chemetron Health Systems
- **Product Code:** [EBW](/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW.md)
- **Decision Date:** Jan 28, 1977
- **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/EBW/K770129](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K770129)

**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