Hu-Friedy Dental Cartridge Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120659 FDA 510(k)
- FDA Product Code
- EJI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6770 FDA 510(k)
- Regulation Number
- 872.6770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hu-Friedy Dental Cartridge Syringe is a Syringe, Cartridge designed for dental applications. It delivers precise fluid dispensing, commonly used for local anesthetics, irrigants, or other dental medications in controlled volumes.
This device is supplied as a single-use, non-sterile item and is classified under FDA regulation 872.6770 as a Class II medical device. It is intended for use in dental offices and clinics, with multiple cartridge sizes available for compatibility with dental anesthesia systems. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of November 6, 2012.
Frequently asked questions
What is the primary use of the Hu-Friedy Dental Cartridge Syringe in clinical settings?
The Hu-Friedy Dental Cartridge Syringe is designed for dental applications to deliver precise fluid dispensing, most commonly used for administering local anesthetics, irrigants, or other dental medications in controlled volumes. Its precision ensures accurate delivery during procedures like injections or cavity preparations.
Are these syringes intended for single-use or reusable applications?
The Hu-Friedy Dental Cartridge Syringe is explicitly labeled as a single-use device. This design choice helps maintain sterility and hygiene in dental settings, reducing cross-contamination risks between patients.
Is the Hu-Friedy Dental Cartridge Syringe sterile when supplied?
No, the device is supplied in a non-sterile state. It is intended to be used in dental offices and clinics where sterilization protocols (e.g., autoclaving or chemical sterilization) are applied to the syringe system before patient use, ensuring safety for clinical procedures.
How many cartridge sizes are available for compatibility with dental anesthesia systems?
The Hu-Friedy Dental Cartridge Syringe comes in multiple cartridge sizes, as indicated by the extensive list of FDA registration numbers (e.g., 3014334038, 3003882399, etc.). These variations ensure compatibility with a wide range of dental anesthesia systems, accommodating different procedural needs and syringe models.
What regulatory pathway was followed for FDA clearance of this device?
The Hu-Friedy Dental Cartridge Syringe received FDA clearance through the Traditional 510(k) pathway, with a decision date of November 6, 2012. It was determined to be substantially equivalent to a legally marketed predicate device, classified under FDA regulation 872.6770 as a Class II medical device for dental use.
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: Dental Syringes - HuFriedyGroup, Hu-Friedy - Premium Dental Instruments & Equipment, Hu-Friedy, Aspirating Syringes - safcodental.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120659 | Class II | Active |
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Manufacturer
- Manufacturer
- Hu-Friedy Mfg. Co., Llc
Sources (1)
- FDA 510(k) K120659 24 fields · synced Sep 19, 2026