Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A dental ultrasonic cleaner is a tank that cleans used instruments with high-frequency sound waves and a cleaning solution. It is a cleaning step, not a sterilizer: the CDC describes cleaning as the first step before disinfection or sterilization. This page is for dental health care personnel, practice managers and students who need to know where the device fits, how FDA regulates it, and what the evidence says affects results.
What a dental ultrasonic cleaner is
FDA defines an ultrasonic cleaner for medical instruments in 21 CFR 880.6150 as a device intended for cleaning medical instruments using the emission of high-frequency sound waves. The same regulation classifies it as Class I, and the device and the solutions used with it are exempt from premarket notification (510(k)), subject to the limitations in 21 CFR 880.9. The purpose in a dental setting is to remove debris from reusable instruments before they are sterilized.
The physics of cavitation is covered in how an ultrasonic cleaner works, so it is not repeated here. This page stays on the dental-office question: where the unit sits in instrument reprocessing and what the primary sources say about using it.
Who uses it: dental health care personnel (the CDC’s term, DHCP) who reprocess reusable instruments.
Where it fits in instrument reprocessing
The CDC’s dental infection control guidance states that cleaning is the basic first step in all decontamination processes, and that leftover contamination can cause disinfection or sterilization to fail. It also says automated cleaning equipment, with the ultrasonic cleaner and the washer-disinfector given as examples, should be used to remove debris, and that reusable dental equipment should be cleaned and reprocessed according to the manufacturer’s instructions.
In practice that places the ultrasonic cleaner before the sterilizer, not in place of it. See dental autoclave for the sterilization step and cleaning and sterilizing surgical instruments for the wider sequence.
Manual cleaning, ultrasonic cleaning and washer-disinfectors
The CDC describes two routes to cleaning: manual scrubbing and automated equipment. The table summarizes what the CDC pages say about each.
| Method | What the CDC says | Key difference |
|---|---|---|
| Manual cleaning | Scrub with a surfactant or detergent and water. | Hands-on contact with contaminated instruments. |
| Ultrasonic cleaner | Named as automated cleaning equipment used with chemical agents; automated cleaning can be more efficient and safer than manually cleaning contaminated instruments. | Agitation by the unit rather than by scrubbing. |
| Washer-disinfector | Named alongside the ultrasonic cleaner as automated cleaning equipment that should be used to remove debris. | A different device; see washer-disinfector. |
An ultrasonic scaler, the handpiece used on teeth, is a different device from the cleaning tank described here; see dental scaler.
What affects cleaning results
A 2025 laboratory study in the International Dental Journal (Seneviratne and colleagues) tested 13 commercial ultrasonic detergents and holding solutions on artificial organic soil. Its reported findings, in brief:
- Enzymatic products consistently outperformed non-enzymatic products at removing organic bioburden.
- Ultrasonic agitation performed better than static soaking.
- Many products failed when used at their minimum recommended concentration.
These are bench results with test soil on simple stainless steel in tap water of 208 ppm hardness, using standardized test soil and strips. They show which variables mattered in that study; they are not instructions for a clinic. The manufacturer’s instructions for use for both the unit and the solution govern, as the CDC states. For solution types, see ultrasonic cleaner solution.
Safe use and handling basics
- Follow the manufacturer’s instructions for the unit and for the cleaning and disinfection products selected; the CDC says DHCP should follow manufacturer recommendations for these products.
- Wear appropriate personal protective equipment when handling and reprocessing contaminated patient equipment.
Common mistakes
- Treating cleaning as sterilization. The CDC places cleaning before sterilization because leftover contamination can make later steps fail.
- Ignoring the manufacturer’s instructions. The CDC directs reprocessing according to manufacturer instructions, including for the solutions used.
FAQ
Is a dental ultrasonic cleaner regulated by FDA?
Yes. 21 CFR 880.6150 classifies an ultrasonic cleaner for medical instruments as Class I, and the device and its solutions are exempt from premarket notification, subject to the limitations in 21 CFR 880.9 (checked 2026-10-30).
Does an ultrasonic cleaner sterilize instruments?
No. FDA’s definition is of a device intended for cleaning. The CDC describes cleaning as the first step before disinfection or sterilization.
Does the CDC recommend automated cleaning?
The CDC’s dental summary states that automated cleaning equipment, such as an ultrasonic cleaner or washer-disinfector, should be used to remove debris, and that it can be more efficient and safer than manual cleaning.
Sources
- FDA, 21 CFR 880.6150, Ultrasonic cleaner for medical instruments: eCFR (checked 2026-10-30).
- CDC, Sterilization and Disinfection, summary of dental infection prevention and control practices (page dated May 15, 2024): cdc.gov (checked 2026-10-30).
- CDC, Best Practices for Sterilization in Dental Settings (page dated May 15, 2024): cdc.gov (checked 2026-10-30).
- Seneviratne CJ et al., International Dental Journal, 2025 (online March 25, 2025): PubMed Central (checked 2026-10-30).
