MiniMaster LED Ultrasonic Scaler
by E.M.S. Electro Medical Systems S.A. Switzerland 510(k)
510(k) K093723 Product code ELC
Overview
The MiniMaster LED Ultrasonic Scaler is a Class II dental device designed for ultrasonic scaling in oral healthcare. It combines ultrasonic technology with LED illumination to enhance precision during dental cleaning procedures, targeting calculus and plaque removal from teeth surfaces.
This device is supplied as a reusable, non-sterile instrument intended for use in dental offices. It operates with an external power supply and includes irrigation capabilities. Authorized under FDA 510(k) clearance (K093723) as a Scaler, Ultrasonic under regulation 872.4850, it adheres to dental specialty standards and is classified under product code ELC.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093723 | Date8 Sep 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ems Minimaster LED
- 510(k) Number
- FDA Product Code
- ELC
- FDA applicant
- E.M.S Electro Medical Systems S.A
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from E.M.S. Electro Medical Systems S.A.
Questions
What is the primary purpose of the EMS MiniMaster LED in dental procedures?
The EMS MiniMaster LED is designed specifically for ultrasonic scaling in dental care, combining ultrasonic technology with LED illumination to improve precision during the removal of calculus and plaque from tooth surfaces. The LED feature enhances visibility, helping clinicians target hard-to-reach areas during cleaning.
Is the EMS MiniMaster LED intended for single-use or reusable applications in a dental office?
The EMS MiniMaster LED is supplied as a reusable instrument, meaning it is intended for repeated use in dental offices after proper cleaning and maintenance. It is not a single-use device, so sterilization protocols must be followed between patients to ensure safety and compliance.
How is the EMS MiniMaster LED powered, and does it include any additional features?
The EMS MiniMaster LED operates using an external power supply, as indicated in its specifications. It also includes irrigation capabilities, which help flush away debris during the scaling process, improving efficiency and patient comfort.
What regulatory pathway was followed for the FDA clearance of the EMS MiniMaster LED?
The EMS MiniMaster LED received FDA clearance through a traditional 510(k) process, specifically under the classification of a Scaler, Ultrasonic (product code ELC). The device was determined to be substantially equivalent to a predicate product and was reviewed by the Dental (DE) Advisory Committee.
What should clinicians know about the sterility and handling of the EMS MiniMaster LED?
The EMS MiniMaster LED is supplied in a non-sterile condition, meaning it must be sterilized before first use and after each patient encounter in a dental office. Proper sterilization and maintenance procedures are critical to ensure safety and functionality, as it is a reusable device.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K093723