Model 3003 Scaler

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

Full name

The Model 3003 Scaler

510(k) Number

K930698 ↗

FDA Product Code

ELC

Device Class

Class II

Regulation

21 CFR Part 872.4850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Model 3003 Scaler in dental procedures?

  The Model 3003 Scaler is designed specifically for removing dental plaque, stains, and calculus from teeth during professional cleaning. It uses high-frequency ultrasonic vibrations to disrupt and eliminate biofilm and hardened deposits, supporting periodontal therapy and maintaining oral hygiene.

• Is the Model 3003 Scaler intended for single-use or reusable applications?

  The Model 3003 Scaler is a reusable instrument. It must be properly sterilized between patient use to ensure safety and hygiene in dental offices or clinics.

• What environmental conditions are required for optimal performance and storage of the Model 3003 Scaler?

  The device operates best within a temperature range of 0–35°C and relative humidity below 80%. Storage conditions must maintain pressure between 70–106kPa to preserve functionality.

• How is the Model 3003 Scaler powered, and what are its electrical specifications?

  The Model 3003 Scaler runs on a 3.7VDC power supply with an output of 2.8W. These specifications ensure efficient ultrasonic performance for dental scaling.

• What regulatory pathway was followed for the FDA clearance of the Model 3003 Scaler?

  The Model 3003 Scaler received FDA clearance through a 510(k) submission (K930698) under product code ELC, classified as a Class II medical device. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device.