EMS Surface Mount Ultrasonic Scaler
by (Ems Sa) Electro Medical Systems
510(k) K991874
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991874 | Date30 Jul 1999 | 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- Withdrawn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
- Ems Surface Mount 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, 1 Oct 2026
The EMS Surface Mount Ultrasonic Scaler is a dental device classified as an ultrasonic scaler. It is designed for the removal of supra and subgingival calculus deposits and stains from teeth, periodontal pocket lavage with simultaneous ultrasonic tip movement, and scaling and root planing. This device operates using ultrasonic vibrations to efficiently clean dental surfaces while minimizing patient discomfort.
The EMS Surface Mount Ultrasonic Scaler is intended for use in dental offices by dental professionals. It is a reusable device and is not described as sterile upon packaging. The device is classified as a Class 2 medical device under FDA regulations (872.4850) and was cleared through the FDA 510(k) pathway (K991874) in 1999. No specific MRI safety information or size variations are noted in the available data.
Other devices from Electro Medical Systems (Ems Sa)
Questions
AI-generated answers, 1 Oct 2026
What is the EMS Surface Mount Ultrasonic Scaler used for?
The EMS Surface Mount Ultrasonic Scaler is designed for dental professionals to remove supra and subgingival calculus deposits and stains from teeth. It also facilitates periodontal pocket lavage while moving the ultrasonic tip, making it suitable for scaling and root planing procedures. The device uses ultrasonic vibrations to clean dental surfaces effectively while reducing patient discomfort.
Is the EMS Surface Mount Ultrasonic Scaler reusable or single-use?
The EMS Surface Mount Ultrasonic Scaler is a reusable device. It is not supplied sterile, meaning it requires cleaning, disinfection, and sterilization between uses in a dental office setting to maintain safety and hygiene standards.
What regulatory pathway was followed for the EMS Surface Mount Ultrasonic Scaler?
The EMS Surface Mount Ultrasonic Scaler was cleared through the FDA 510(k) pathway under the classification of a Class 2 medical device (FDA product code: ELC). It was determined to be substantially equivalent to a predicate device and received clearance with the FDA 510(k) number K991874 in 1999.
Are there different sizes or models available for the EMS Surface Mount Ultrasonic Scaler?
The provided data does not specify any size variations or distinct models for the EMS Surface Mount Ultrasonic Scaler. It is important to confirm with the manufacturer if specific configurations or attachments are available for different clinical needs.
How should the EMS Surface Mount Ultrasonic Scaler be stored?
Since the EMS Surface Mount Ultrasonic Scaler is a reusable device, it should be stored in a clean, dry environment when not in use. Proper storage includes keeping it in its original packaging or a designated storage area to prevent contamination. Follow manufacturer guidelines for maintenance and cleaning procedures to ensure optimal performance and longevity.