Ligmaject
by Alan J. Khedarri D.D.S., Inc.
510(k) K802483
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802483 | Date12 Nov 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EJI
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6770
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Ligmaject Syringe and Cartridge is a dental syringe and cartridge system designed for the delivery of dental materials. According to the FDA classification, it falls under the category of a syringe, intended for use in dental procedures requiring precise fluid application.
This device is supplied as a reusable syringe paired with single-use cartridges, intended for use in dental offices. It has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II medical device under regulation number 872.6770. The system is not indicated for MRI use and must be handled according to standard dental instrument sterilization protocols.
Questions
AI-generated answers, 19 Sep 2026
What types of dental materials can the Ligmaject Syringe and Cartridge system deliver, and how is it different from standard dental syringes?
The Ligmaject system is specifically designed for the precise delivery of dental materials, though the exact types of materials it supports are not detailed in the provided data. Unlike standard dental syringes, it is structured as a reusable syringe paired with single-use cartridges, which may offer advantages in sterility control and ease of use for dental offices. The system emphasizes accuracy in fluid application, which is critical for procedures like fillings, sealants, or other restorative treatments.
Is the reusable syringe part of the Ligmaject system sterilizable, and if so, what are the recommended sterilization methods?
Yes, the reusable syringe component of the Ligmaject system must be handled according to standard dental instrument sterilization protocols. This means it should undergo proper cleaning and sterilization between uses, typically via autoclaving or chemical sterilization methods commonly used in dental offices to ensure safety and prevent cross-contamination.
Are there multiple sizes or models of the Ligmaject system, and if so, how can I identify which one is best suited for my practice?
The provided data lists multiple FEI numbers and registration numbers, indicating that the Ligmaject system likely includes several cartridge and syringe variants. While the exact specifications (e.g., cartridge sizes, syringe lengths) are not detailed, these identifiers suggest a range of options tailored for different dental procedures. Consulting the manufacturer’s documentation or a dental supply specialist would help determine which model aligns best with your practice’s specific needs, such as material viscosity or procedural requirements.
Can the Ligmaject system be used in conjunction with MRI equipment, or are there any restrictions?
The Ligmaject system is explicitly noted as not indicated for MRI use. This means it should not be brought into an MRI environment, as the materials or components may interfere with imaging or pose safety risks. Always follow the manufacturer’s guidelines and facility protocols when using dental equipment near MRI machines.
How was the Ligmaject system classified by the FDA, and what does this mean for its use in dental procedures?
The Ligmaject system is classified as a Class II medical device under FDA regulation number 872.6770 and received FDA 510(k) clearance through the Traditional pathway. This classification means it is subject to stricter controls than Class I devices but does not require the same level of scrutiny as Class III devices. For users, this indicates that the system has undergone evaluation to ensure its safety and effectiveness for dental procedures requiring precise fluid application, such as injections or material delivery.