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Pneumatic Dental Scaler

by Innovate, Inc.

510(k) K811145

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811145 Date16 Jun 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ELC
Device Class
Class II
Regulation
21 CFR Part 872.4850
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pneumatic Dental Scaler is a dental device classified as a Scaler, Ultrasonic under FDA nomenclature. It employs low-pressure air to generate oscillatory motion in a scaling tip, facilitating the removal of dental plaque and calculus from teeth surfaces during professional cleaning procedures.

This device is designed for single-use in clinical settings and has received FDA 510(k) clearance under product code ELC. It is intended for use by dental professionals and is regulated under 21 CFR 872.4850. The device is supplied as a handpiece and requires connection to an air supply for operation.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • How is the Pneumatic Dental Scaler intended to be used in a clinical setting?

    The Pneumatic Dental Scaler is designed for professional dental cleaning procedures to remove dental plaque and calculus from teeth surfaces. It uses low-pressure air to create oscillatory motion in a scaling tip, making it suitable for use by dental professionals during scaling and polishing treatments. It is not intended for home use or self-administration.

  • Is the Pneumatic Dental Scaler reusable or single-use, and what does this mean for my practice?

    The Pneumatic Dental Scaler is explicitly designed for single-use only in clinical settings. This means each handpiece is intended to be used once and then discarded, reducing the risk of cross-contamination between patients. Your practice will need to account for this in inventory management and waste disposal protocols.

  • What air supply requirements does the Pneumatic Dental Scaler have, and how is it supplied?

    The device is supplied as a handpiece only and requires connection to an external air supply for operation. No additional power source (like electricity) is needed—only a compatible compressed air line. Ensure your clinic’s air supply meets the device’s specifications for proper functionality.

  • What regulatory pathway was followed for FDA clearance of the Pneumatic Dental Scaler?

    The Pneumatic Dental Scaler received FDA 510(k) clearance under product code ELC, classified as a Scaler, Ultrasonic. The submission was reviewed by the Dental Devices Panel (DE) and determined to be *substantially equivalent* to a legally marketed device. The clearance was granted on June 16, 1981, under 21 CFR 872.4850.

  • Are there different sizes or models of the Pneumatic Dental Scaler available?

    The provided data does not specify multiple sizes or models of the Pneumatic Dental Scaler. It is described as a single device type (a handpiece) with no variations listed. For exact specifications, confirm with Innovate, Inc. or check their latest product catalog, as additional models may exist beyond the regulatory submission details.