Amdent Model 830 Ultrasonic Scaler
510(k) K880940
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880940 | Date15 Jul 1988 | 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- Withdrawn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, 1 Oct 2026
The Amdent Model 830 Ultrasonic Scaler is a Class II dental device designed for ultrasonic cleaning. It uses high-frequency vibrations to remove plaque, calculus, and biofilm from teeth and periodontal pockets during dental prophylaxis and periodontal therapy. This mechanism helps in scaling and root planing procedures, contributing to periodontal health management.
This device is supplied as a reusable instrument intended for use in dental clinics and offices. It operates on electrical power and is not classified as single-use or sterile upon packaging. The Model 830 is MRI-unsafe due to its metallic components and electrical components, requiring removal before MRI procedures. Authorized under FDA 510(k) clearance (K880940) as substantially equivalent, it adheres to regulatory standards outlined in 21 CFR 872.4850 for ultrasonic scalers.
Questions
AI-generated answers, 1 Oct 2026
What is the Amdent Model 830 Ultrasonic Scaler used for?
The Amdent Model 830 Ultrasonic Scaler is designed for ultrasonic cleaning in dental procedures. It employs high-frequency vibrations to effectively remove plaque, calculus, and biofilm from teeth and periodontal pockets, making it ideal for scaling and root planing during dental prophylaxis and periodontal therapy. This helps maintain periodontal health by ensuring thorough cleaning of hard-to-reach areas.
Is the Amdent Model 830 Ultrasonic Scaler single-use or reusable?
The Amdent Model 830 Ultrasonic Scaler is supplied as a reusable instrument. It is intended for repeated use in dental clinics and offices, provided it is properly cleaned, maintained, and sterilized between procedures. This design allows for cost-effective operation while ensuring consistent performance.
Is the Amdent Model 830 Ultrasonic Scaler sterile upon packaging?
No, the Amdent Model 830 Ultrasonic Scaler is not sterile upon packaging. It is a reusable device and must be cleaned and sterilized by the dental facility before each use. Proper sterilization is critical to prevent cross-contamination and ensure patient safety.
Can the Amdent Model 830 Ultrasonic Scaler be used in an MRI environment?
No, the Amdent Model 830 Ultrasonic Scaler is MRI-unsafe due to its metallic and electrical components. It must be removed from the patient and the surrounding area before undergoing an MRI procedure to avoid interference or safety hazards.
What regulatory clearance does the Amdent Model 830 Ultrasonic Scaler hold?
The Amdent Model 830 Ultrasonic Scaler holds FDA 510(k) clearance under the reference number K880940. It is classified as substantially equivalent to a predicate device and adheres to regulatory standards outlined in 21 CFR 872.4850 for ultrasonic scalers, ensuring compliance with U.S. medical device regulations.