Neo Dental Endodontic Irrigation Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K955703 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a resin-based root canal filling syringe used for endodontic irrigation. It is designed to deliver irrigants into the root canal system during dental procedures.
The syringe is supplied as a reusable device, autoclavable for up to 50 uses, and is compatible with all irrigation liquids. It has a calibrated 5.5ml capacity and a narrow tip for precise delivery. Authorization is based on FDA 510(k) clearance K955703, issued in 1996, and it is classified as a Class II medical device under regulation number 872.3820.
Frequently asked questions
How many times can this syringe be reused before needing replacement or reprocessing?
The NEO DENTAL ENDODONTIC IRRIGATION SYRINGE is designed as a reusable device and can be autoclaved up to 50 times before it should be replaced or reprocessed. This allows for cost-effective use in clinical settings while maintaining hygiene standards.
What types of irrigation liquids is this syringe compatible with, and why is this important?
The syringe is explicitly designed to be compatible with *all* irrigation liquids used in endodontic procedures, such as sodium hypochlorite, EDTA, or chlorhexidine. This versatility ensures clinicians can use their preferred irrigant without worrying about material incompatibility, which could compromise treatment efficacy or syringe integrity.
What is the capacity of the syringe, and how does the tip design support its clinical use?
The syringe has a 5.5 mL calibrated capacity, providing precise control over fluid delivery during root canal irrigation. Its narrow tip allows for targeted, minimally invasive access to the root canal system, reducing the risk of overfilling or extruding irrigants into surrounding tissues—a critical factor in maintaining procedural accuracy and patient safety.
How should this syringe be stored to ensure its longevity and sterility between uses?
Since the syringe is reusable and autoclavable, it should be stored in a clean, dry environment after each use and before reprocessing. After autoclaving (up to 50 cycles), it should be kept in a sealed, sterile packaging or a dedicated storage case to prevent contamination until the next procedure. Proper storage preserves its structural integrity and ensures sterility for repeated use.
What regulatory pathway was followed for this device’s FDA clearance, and what does that mean for clinicians?
The NEO DENTAL ENDODONTIC IRRIGATION SYRINGE received FDA 510(k) clearance (K955703) in 1996 under a Traditional 510(k) review, demonstrating it was found *substantially equivalent* to a legally marketed predicate device. Clinicians can rely on this clearance as evidence that the syringe meets established safety and performance standards for endodontic irrigation, though they should always follow manufacturer guidelines for use and reprocessing.
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: NEO DENTAL ENDODONTIC IRRIGATION SYRINGE (K955703) — FDA 510 (k ..., PDF K955703 - Neo Dental Endodontic Irrigation Syringe, Neo Dental International, Inc. > Products > Multiflex Syringe, Neo Dental Chemical Products Co L T D FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955703 | Class II | Active |
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Manufacturer
- Manufacturer
- Neodental Chemical Products Co., Ltd.
Sources (1)
- FDA 510(k) K955703 24 fields · synced Oct 6, 2026