Scaletron Piezo Ultrasonic Scaler
by Pac-Dent International (Suzhou), Ltd.
510(k) K033120
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033120 | Date29 Jan 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Scaletron Piezo Ultrasound Scaler
- 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, 20 Sep 2026
The Scaletron Piezo Ultrasonic Scaler is a dental device classified as an ultrasonic scaler, designed for the removal of calculus and stains from teeth. It employs piezoelectric technology to generate high-frequency vibrations, which facilitate efficient and precise cleaning of dental surfaces during scaling procedures. This device is intended for use in clinical dental settings to assist in periodontal therapy and restorative dentistry by addressing subgingival and supragingival deposits.
The Scaletron Piezo Ultrasonic Scaler is supplied as a reusable device, comprising a main unit with an integrated water pump, a hose, a handpiece, and a foot control switch. It operates in non-sterile environments, requiring sterilization between patient uses in accordance with dental infection control protocols. The device is classified under FDA regulation number 872.4850 and holds a 510(k) clearance (K033120) for dental use, with a product code of ELC. Multiple model references are associated with its regulatory submission, ensuring compliance with U.S. dental device standards.
Other devices from Pac-Dent International (Suzhou), Ltd.
Questions
AI-generated answers, 20 Sep 2026
What clinical procedures is the Scaletron Piezo Ultrasonic Scaler primarily used for in dental settings?
The Scaletron Piezo Ultrasonic Scaler is designed for removing calculus and stains from teeth, making it ideal for periodontal therapy and restorative dentistry. It efficiently cleans both subgingival (below the gumline) and supragingival (above the gumline) deposits, supporting scaling procedures during dental treatments.
How is the Scaletron Piezo Ultrasonic Scaler supplied, and what components are included?
The device is supplied as a reusable system, including a main unit with an integrated water pump, a hose, a handpiece for direct use, and a foot control switch for hands-free operation. This setup allows for efficient scaling while maintaining ergonomic control.
Is the Scaletron Piezo Ultrasonic Scaler pre-sterilized, and how should it be handled between patient uses?
The Scaletron Piezo Ultrasonic Scaler is not supplied in a sterile state—it operates in non-sterile environments. Between patient uses, it must be thoroughly sterilized following standard dental infection control protocols to ensure patient safety and device longevity.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?
The Scaletron Piezo Ultrasonic Scaler received FDA 510(k) clearance (K033120) under the traditional review process, with a determination of *substantially equivalent* to predicate devices. This means it meets FDA standards for safety and effectiveness as a dental ultrasonic scaler, classified under product code ELC and regulation 872.4850. Buyers can rely on its compliance with U.S. dental device regulations.
Are there multiple model variants of the Scaletron Piezo Ultrasonic Scaler, and how does this affect compatibility?
Yes, the device is associated with multiple model references (listed in the regulatory submission) to cover various configurations or updates. While these references reflect regulatory filings, compatibility between models should be confirmed with the manufacturer (Pac-Dent International) to ensure proper functionality, sterilization protocols, and part interchangeability in clinical settings.