Lysta Hygienist III Scaler
510(k) K904296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904296 | Date5 Dec 1990 | 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- Withdrawn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
- 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 Lysta Hygienist III Scaler is an Ultrasonic Scaler, a dental device designed for the removal of plaque, calculus, and biofilm from teeth and surrounding structures. It operates using high-frequency vibrations to disrupt and loosen deposits through cavitation and acoustic streaming, aiding in periodontal debridement and oral hygiene procedures.
This device is supplied as a reusable, non-sterile instrument intended for use in dental clinics and offices. It requires cleaning and maintenance between patient applications, adhering to standard infection control protocols. The Lysta Hygienist III Scaler is classified under FDA regulation 872.4850 and holds a 510(k) clearance (K904296) for dental use, with no specific MRI safety restrictions noted. Multiple model variants are listed under the ELC product code, reflecting different configurations or attachments.
Other devices from Prodent Intl., Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Lysta Hygienist III Scaler in dental procedures?
The Lysta Hygienist III Scaler is designed for removing plaque, calculus, and biofilm from teeth and surrounding structures during periodontal debridement and oral hygiene procedures. It uses high-frequency ultrasonic vibrations to disrupt and loosen deposits through cavitation and acoustic streaming, making it effective for scaling and cleaning teeth.
Is the Lysta Hygienist III Scaler intended for single-use or reusable applications?
The Lysta Hygienist III Scaler is a reusable instrument, not intended for single-use. It requires cleaning and maintenance between patient applications to adhere to standard infection control protocols in dental clinics.
What types of attachments or model variants are available for the Lysta Hygienist III Scaler?
The Lysta Hygienist III Scaler includes multiple model variants, as indicated by the diverse list of FEI numbers (e.g., 3038718579, 2127132, etc.) under the ELC product code. These variants likely correspond to different configurations or attachments, allowing for flexibility in dental procedures.
How should the Lysta Hygienist III Scaler be stored, and are there any special considerations?
Since the device is reusable and non-sterile, it must be cleaned and maintained properly between uses to prevent contamination. While specific storage instructions aren’t detailed in the data, standard dental practice guidelines for ultrasonic scalers—such as keeping it in a clean, dry environment and following manufacturer recommendations—should be followed to ensure longevity and functionality.
What regulatory pathway was followed for the FDA clearance of the Lysta Hygienist III Scaler?
The Lysta Hygienist III Scaler received FDA clearance through a 510(k) submission (K904296), classified under Traditional 510(k) review with a Substantially Equivalent (SESE) determination. It falls under FDA regulation 872.4850 for ultrasonic scalers and was filed with the Dental (DE) Advisory Committee in 1990.