Meet Endo-II Integrated Endo System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242317 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Meet Endo-II Integrated Endo System is a Class II dental device designed for endodontic procedures. It combines an endodontic motor for root canal cleaning, an ultrasonic handpiece for canal preparation, an electronic apex locator for precise tip positioning, and an obturator for filling and pressurizing root canals. This integrated system streamlines endodontic workflows by consolidating multiple functions into a single unit, enhancing efficiency and accuracy in root canal therapy.
The Meet Endo-II Integrated Endo System is supplied for use in dental clinics and endodontic offices. It is a reusable device with non-sterile components, requiring sterilization between patient uses. The system is not MRI-compatible and includes multiple model variants, as referenced by the FEI numbers. Authorized under an FDA 510(k) clearance (K242317), it complies with regulatory standards for dental instruments under the classification ELC (Endodontic Equipment).
Meet Endo-II Integrated Endo System
Frequently asked questions
What is the Meet Endo-II Integrated Endo System used for?
The Meet Endo-II Integrated Endo System is designed for endodontic procedures, specifically root canal therapy. It consolidates multiple functions—root canal cleaning via an endodontic motor, ultrasonic canal preparation, precise tip positioning with an electronic apex locator, and filling/pressurizing canals with an obturator—into a single unit. This integration streamlines workflows, improving efficiency and accuracy in dental clinics and endodontic offices.
How is the Meet Endo-II Integrated Endo System supplied and prepared for use?
The Meet Endo-II is supplied as a reusable dental device with non-sterile components. Before use with each patient, the system requires sterilization to ensure safety and compliance with infection control protocols. The manufacturer provides guidelines for proper sterilization methods to maintain device integrity and performance.
Is the Meet Endo-II system single-use or reusable, and what does that mean for sterilization?
The Meet Endo-II is a reusable device, meaning it is designed for multiple uses in clinical settings. However, its non-sterile components necessitate sterilization between patient uses. Reusability reduces waste but requires strict adherence to sterilization protocols to prevent cross-contamination and ensure patient safety.
What model variants or FEI numbers are available for the Meet Endo-II Integrated Endo System?
The Meet Endo-II Integrated Endo System includes multiple model variants, each identified by a unique FEI (Foreign Equipment Identifier) number. These numbers include, but are not limited to: 1000160293, 3038718579, 3008981576, 2127132, and others listed in the regulatory records. These variants may differ in specific features or configurations but share the same core functionality for endodontic procedures.
How should the Meet Endo-II Integrated Endo System be stored, and are there any special considerations?
The Meet Endo-II should be stored in a clean, dry environment protected from moisture, dust, and extreme temperatures to preserve its functionality. Since it is reusable and requires sterilization, storage areas should comply with clinical sterilization protocols. Additionally, the system is not MRI-compatible, so it must be stored away from MRI machines to avoid potential damage or interference.
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: PDF Denjoy Meet Endo-II Integrated Endo System User Manual, Meet Endo All-in-One Endodontic System - denjoy, Denjoy Meet Endo-II Integrated Endo System User Manual, K242317 FDA 510 (k) - Integrated Endo System (Meet Endo-II)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242317 | Class II | Active |
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Manufacturer
- Manufacturer
- Denjoy Dental Co., Ltd
- FDA Applicant
- Denjoy Dental Co., Ltd.
Sources (1)
- FDA 510(k) K242317 24 fields · synced Oct 1, 2026