Amdent 2030 Polisher/Scaler
by Amdent AB
510(k) K920328
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920328 | Date20 Oct 1993 | 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- Withdrawn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, 20 Sep 2026
The Amdent 2030 Polisher/Scaler is an ultrasonic dental device designed for removing plaque, calculus, and stains from teeth. It combines polishing and scaling functions to enhance oral hygiene procedures, particularly in professional dental settings. The device operates using ultrasonic vibrations to efficiently clean tooth surfaces while minimizing patient discomfort. Its design supports both preventive and restorative dental care by maintaining optimal oral health.
This device is intended for use in dental clinics and offices by trained professionals. Supplied as a reusable instrument, it requires proper sterilization between patient uses to ensure infection control. The Amdent 2030 Polisher/Scaler is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K920328) for dental use. It adheres to regulatory standards for safety and performance, including compliance with the FDA’s dental device classification (ELC) and registration number 872.4850.
Questions
AI-generated answers, 20 Sep 2026
Is the Amdent 2030 Polisher/Scaler designed for single-use or reusable applications in a dental clinic?
The Amdent 2030 Polisher/Scaler is explicitly designed as a reusable instrument for professional dental settings. Since it requires sterilization between patient uses to ensure infection control, it is not intended for single-use. Proper sterilization procedures must be followed to maintain safety and compliance with dental hygiene standards.
What types of dental procedures is the Amdent 2030 Polisher/Scaler primarily used for, and how does it benefit oral hygiene?
The Amdent 2030 is primarily used for removing plaque, calculus, and stains from teeth during professional dental cleanings. It combines polishing and scaling functions using ultrasonic vibrations, which helps minimize patient discomfort while improving oral hygiene. This makes it useful for both preventive care (regular cleanings) and restorative care (maintaining oral health after treatments).
How is the Amdent 2030 Polisher/Scaler regulated, and what does its FDA clearance indicate?
The Amdent 2030 holds an FDA 510(k) clearance (K920328), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms its compliance with FDA safety and performance standards for Class II dental devices, specifically under the ELC (Electric Light Current) product code (872.4850). It does not imply approval for any specific clinical indication but confirms regulatory acceptance for its intended use in dental scaling and polishing.
Are there different models or sizes available for the Amdent 2030 Polisher/Scaler, and how might they differ?
The provided data does not specify distinct models or sizes for the Amdent 2030 Polisher/Scaler. However, the OpenFDA registration numbers suggest multiple FEI (Facility Establishment Identifier) listings, which may indicate variations in accessories, attachments, or regional configurations. For precise sizing or model differences, consulting the manufacturer’s documentation or sales team is recommended, as these details are not explicitly outlined in the regulatory submission.