Identifiers
- 510(k) Number
- K132609 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EDS Ultrasonic Tips are dental ultrasonic scaler tips used for professional dental procedures. These tips are designed to be compatible with ultrasonic dental scalers for removing plaque, calculus, and other deposits from teeth.
The EDS Ultrasonic Tips are supplied as single-use or reusable devices depending on the specific model. They are available in various sizes and models as specified by the manufacturer. The device has received FDA 510(k) clearance with product code ELC and is classified as Class II by the FDA.
Frequently asked questions
What are EDS Ultrasonic Tips used for?
EDS Ultrasonic Tips are dental ultrasonic scaler tips designed for professional dental procedures. They are compatible with ultrasonic dental scalers and used specifically for removing plaque, calculus, and other deposits from teeth.
Are EDS Ultrasonic Tips single-use or reusable?
The EDS Ultrasonic Tips are supplied as either single-use or reusable devices depending on the specific model selected. The manufacturer offers various options to meet different clinical needs and preferences.
What sizes and models of EDS Ultrasonic Tips are available?
EDS Ultrasonic Tips are available in various sizes and models as specified by the manufacturer. The specific options would be detailed in the product catalog or by contacting Essential Dental Systems, Inc. directly.
What is the regulatory status of EDS Ultrasonic Tips?
The EDS Ultrasonic Tips have received FDA 510(k) clearance with product code ELC and are classified as Class II by the FDA. This indicates they meet the regulatory requirements for safety and effectiveness in dental applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132609 | Class II | Active |
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Manufacturer
- Manufacturer
- Essential Dental Systems, Inc.
Sources (1)
- FDA 510(k) K132609 24 fields · synced Sep 23, 2026