Aseptico VCT Versatile Command Technology Model AEU-925
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K030163 FDA 510(k)
- FDA Product Code
- EKX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aseptico VCT Versatile Command Technology Model AEU-925 is a direct-drive, AC-powered dental handpiece. It is designed for precision rotary instrumentation in dental procedures, delivering controlled torque and speed for cutting, shaping, and polishing dental structures.
This device is supplied as a reusable, non-sterile instrument intended for use in dental clinics and offices. It operates within Class I regulatory classification under FDA 510(k) clearance and EU Medical Device Directives (MDD/MDR). The handpiece requires proper maintenance, including cleaning and sterilization between uses, and must be stored in a clean, dry environment to ensure functionality and safety.
Frequently asked questions
Is this handpiece intended for single-use or can it be reused in a clinical setting?
The Aseptico VCT Model AEU-925 is designed as a reusable dental handpiece. Since it is non-sterile as supplied, it requires cleaning and sterilization between uses to maintain safety and functionality. Proper maintenance, including storage in a clean, dry environment, is essential to ensure reliable performance over multiple procedures.
What regulatory pathways has this device undergone, and how does that affect its use?
The device has received FDA 510(k) clearance under the Traditional 510(k) review pathway, classified as Class I, and complies with EU Medical Device Directives (MDD/MDR). This means it has been evaluated for safety and performance by regulatory authorities, but its intended use is not tied to specific clinical indications—it is instead categorized under dental procedures (product code EKX) for precision rotary instrumentation. Clinicians should follow manufacturer guidelines for cleaning, sterilization, and maintenance.
How should this handpiece be stored to ensure it remains functional and safe for use?
The device must be stored in a clean, dry environment to prevent damage or contamination. Since it is reusable and non-sterile as supplied, it should not be stored in a sterile field. Proper maintenance, including regular cleaning and sterilization between uses, is critical to avoid wear, corrosion, or microbial growth that could compromise performance or patient safety.
What type of power source does this handpiece use, and is it compatible with standard dental clinic setups?
The Aseptico VCT Model AEU-925 is AC-powered, meaning it requires a standard electrical outlet to operate. This makes it compatible with most dental clinic setups that provide electrical power for handpieces. No additional power adapters or specialized wiring are required, as it is designed for direct connection to typical dental office infrastructure.
Are there different models or sizes available for this handpiece, or is it a single unified design?
The provided data specifies only the Model AEU-925 of the Aseptico VCT Versatile Command Technology handpiece, with no mention of additional models or sizes. However, the OpenFDA registration numbers suggest multiple lot or batch identifiers, which may relate to manufacturing variations or recalls—not distinct product models. For specific sizing or alternative configurations, consult the manufacturer’s documentation or sales team, as this device appears to be a single unified design for precision rotary dental procedures.
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 (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K030163 | Class I | Active |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
Sources (2)
- FDA 510(k) K030163 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026