← Product Code [ELB](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB) · K831037

# AIR BURBINE HANDPIECE-DENTAL SCALING (K831037)

_Taco Dental, Inc. · ELB · May 9, 1983 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K831037

## Device Facts

- **Applicant:** Taco Dental, Inc.
- **Product Code:** [ELB](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB.md)
- **Decision Date:** May 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4840
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K831037](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K831037)

**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