Aseptico Endopex V, Model AEU-40
FDA 510(k)EUDAMEDU (US FDA 510(k))
Identifiers
- 510(k) Number
- K030895 FDA 510(k)
- FDA Product Code
- LQY FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aseptico Endopex V, Model AEU-40 is a Locator, Root Apex device, designed to identify the root apex during endodontic procedures. This handheld instrument employs vector-based technology to provide precise localization of the root tip, aiding clinicians in accurate treatment planning and execution.
Supplied as a reusable medical device, the Endopex V is intended for use in dental offices and clinics. It requires no sterility processing as it is not intended for direct patient contact beyond its intended clinical application. The device is classified under FDA product code LQY and has received FDA 510(k) clearance, MDD, and MDR authorizations. Storage and maintenance follow manufacturer guidelines to ensure proper functionality.
Frequently asked questions
What is the primary purpose of the Aseptico Endopex V, Model AEU-40, and how does it assist clinicians during endodontic procedures?
The Aseptico Endopex V, Model AEU-40 is designed as a Locator, Root Apex device that uses vector-based technology to precisely identify the root apex during endodontic treatments. By providing accurate localization of the root tip, it helps clinicians improve treatment planning and execution, reducing the risk of procedural errors like overfilling or underfilling during root canal therapy.
Is the Endopex V reusable, and if so, what maintenance or cleaning guidelines should be followed?
Yes, the Endopex V is supplied as a reusable medical device and is not intended for direct patient contact beyond its clinical application, so it does not require sterile processing. However, to ensure proper functionality, it must be maintained according to the manufacturer’s guidelines, which likely include regular cleaning and inspection to prevent performance degradation.
What regulatory pathways has the Endopex V undergone, and which organizations have authorized its use?
The Endopex V has received FDA 510(k) clearance under product code LQY, indicating it was deemed substantially equivalent to a predicate device. It also holds MDD (Medical Device Directive) and MDR (Medical Device Regulation) authorizations, confirming compliance with European regulatory standards. These approvals validate its safety and performance for use in dental offices and clinics.
Are there multiple models or sizes available for the Endopex V, or is this a single-device solution?
The provided data specifies only one model, the AEU-40, for the Endopex V. There is no indication of additional models or sizes in the documentation, suggesting this is a single-device solution designed for general use in endodontic procedures without customization options.
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. Sources consulted: ASEPTICO ENDOPEX V, MODEL AEU-40 - fda.innolitics.com, Aseptico AEU-40 Endopex V Operation And Maintenance ... - ManualsLib, Aseptico AEU-40 Endopex V Manuals | ManualsLib, K030895 FDA 510 (k) - ASEPTICO ENDOPEX V | Aseptico, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | U | Active |
| EUDAMED | European Union | MDD | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K030895 | U | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aseptico, Inc.
Sources (2)
- FDA 510(k) K030895 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026