ZENITH
by Jeneric Ind.
510(k) K833145
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833145 | Date28 Nov 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- Withdrawn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
- EJH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3710
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
ZENITH is a dental alloy, metal, base device. It is classified as a Class 2 medical device under product code EJH and regulation number 872.3710.
ZENITH received FDA 510(k) clearance (K833145) on November 28, 1983, from Jeneric Ind. It is a traditional 510(k) submission and is not a third-party reviewed device.
Other devices from Jeneric Ind.
Questions
AI-generated answers, 25 Sep 2026
What is the ZENITH device used for?
ZENITH is a dental alloy, metal, base device intended for use in dental applications as a Class 2 medical device under product code EJH and regulation number 872.3710, as specified in its FDA 510(k) clearance.
How was the ZENITH device cleared for market?
ZENITH received FDA 510(k) clearance (K833145) on November 28, 1983, through a traditional submission process, demonstrating substantial equivalence to a predicate device, and was not reviewed by a third party.
Who manufactures the ZENITH device and where is it located?
ZENITH is manufactured by Jeneric Ind., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as indicated in the device’s registration and address details.