Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4840](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4840) → ELB — Scaler, Rotary

# ELB · Scaler, Rotary

_Dental · 21 CFR 872.4840 · Class 2_

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

## Overview

- **Product Code:** ELB
- **Device Name:** Scaler, Rotary
- **Regulation:** [21 CFR 872.4840](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4840)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K170596](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K170596.md) | TN-Brush | Genoss Co., Ltd. | Sep 11, 2017 | SESE |
| [K121114](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K121114.md) | TIGRAN PERIBRUSH | Tigran Technologies AB | Sep 17, 2012 | SESE |
| [K111724](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K111724.md) | STRAUMANN TIBRUSH | Straumann USA | Sep 12, 2011 | SESE |
| [K003640](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K003640.md) | MINIENDO III | Sybron Dental Specialties, Inc. | Feb 22, 2001 | SESE |
| [K831037](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K831037.md) | AIR BURBINE HANDPIECE-DENTAL SCALING | Taco Dental, Inc. | May 9, 1983 | SESE |
| [K782007](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELB/K782007.md) | ROTARY SCALER | Star Dental Mfg. Co. | Jan 3, 1979 | SESE |

## Top Applicants

- Genoss Co., Ltd. — 1 clearance
- Star Dental Mfg. Co. — 1 clearance
- Straumann USA — 1 clearance
- Sybron Dental Specialties, Inc. — 1 clearance
- Taco Dental, Inc. — 1 clearance

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

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