Piezo Tronic Ultrasonic Scaler
by Advanced Medical Devices, Inc.
510(k) K982793
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982793 | Date28 Oct 1998 | 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- Withdrawn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
- Piezo Tronic
- 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
The Piezo Tronic Ultrasonic Scaler is a dental device classified as an ultrasonic scaler, designed for the removal of plaque and calculus from teeth. It operates using high-frequency ultrasonic vibrations to disrupt and loosen dental deposits, facilitating their removal during professional dental cleaning procedures.
Used in clinical dental settings by dentists or dental hygienists, the device consists of a main chassis housing an ultrasonic generator, water control valve, and power supply, connected to a handpiece with a stainless steel scaler tip. Activation occurs via a footswitch, which simultaneously triggers ultrasonic vibration of the tip. The device is cleared for use under FDA 510(k) authorization (K982793) as a Class 2 Dental device with product code ELC, following a traditional review pathway.
Other devices from Advanced Medical Devices, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Piezo Tronic Ultrasonic Scaler in dental procedures?
The Piezo Tronic Ultrasonic Scaler is designed specifically for the removal of plaque and calculus from teeth during professional dental cleanings. It uses high-frequency ultrasonic vibrations to disrupt and loosen dental deposits, making them easier to remove with minimal manual effort. This is particularly useful for scaling during routine dental hygiene procedures.
How is the Piezo Tronic Ultrasonic Scaler activated, and what components does it include?
The Piezo Tronic Ultrasonic Scaler is activated via a footswitch, which simultaneously triggers the ultrasonic vibration of the stainless steel scaler tip. The device consists of a main chassis housing the ultrasonic generator, water control valve, and power supply, connected to a handpiece with the scaler tip. This setup allows for precise control during cleaning.
Is the Piezo Tronic Ultrasonic Scaler intended for single-use or reusable applications?
The device description does not explicitly state whether the Piezo Tronic Ultrasonic Scaler is single-use or reusable. However, based on its design as a professional dental tool with replaceable tips and a durable chassis, it is likely intended for reusable applications in clinical settings, following proper cleaning and sterilization protocols. Always verify with manufacturer guidelines for specific usage instructions.
What regulatory pathway was followed for the FDA clearance of the Piezo Tronic Ultrasonic Scaler?
The Piezo Tronic Ultrasonic Scaler was cleared through the FDA’s 510(k) traditional review pathway under the product code ELC, classified as a Class 2 Dental device. The clearance (K982793) was granted in 1998, with a determination of substantially equivalent to a predicate device, as part of the Dental (DE) advisory committee review process.
Are there multiple tip sizes or models available for the Piezo Tronic Ultrasonic Scaler?
The provided data includes multiple FEI numbers (e.g., 3038718579, 2020943), which may correspond to different tip configurations or models of the Piezo Tronic Ultrasonic Scaler. While the exact sizes or variations aren’t detailed, the presence of these identifiers suggests the device may offer multiple tip options to accommodate different dental procedures or patient needs. For precise sizing or model specifications, refer to the manufacturer’s catalog or technical documentation.