E-Z JECTOR
510(k) K830042
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830042 | Date26 Jan 1983 | 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- Withdrawn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, 25 Sep 2026
The E-Z JECTOR is a dental syringe and cartridge device classified as a Class II medical device. It is intended for use in dental procedures to facilitate the delivery of materials or medications.
The device is supplied sterile and is intended for single use. It is not reusable and does not have specific MRI safety information provided. Storage requirements are not detailed in the specifications.