Product code EJS: 510(k) clearances and predicates
Product code EJS covers BRIGHT GOLD XH. FDA lists 194 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
194 clearances on file under product code EJS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest EJS clearances in the FDA index, with applicant and decision date:
- K041433, BRIGHT GOLD XH, applicant Ivoclar Vivadent, Inc., decided 2004-08-19. FDA record
- K040436, SIMIDUR SUPERIOR, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2004-03-05. FDA record
- K022252, STERNGOLD 1, MODEL 1127781, applicant Sterngold, decided 2002-09-19. FDA record
- K022469, ECO E4, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2002-09-18. FDA record
- K021367, STERNGOLD 66, MODEL #1180230, applicant Sterngold, decided 2002-05-16. FDA record
- K020194, SIMIDUR KF PLUS, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2002-03-15. FDA record
- K020195, SIMIDUR S1S, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2002-03-15. FDA record
- K020192, SIMIDUR S2, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2002-03-15. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SIMIDUR SUPERIOR, STERNGOLD 1, MODEL 1127781. Watch new EJS clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code EJS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EJS clearances include BRIGHT GOLD XH.
How many 510(k) clearances use product code EJS?
194 at the time this page was generated, from openFDA records.
How do I find a predicate device under EJS?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new EJS clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for EJS, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free EJS brief
Tell us where to send it. No card required.
You are on the list.
We will email your free EJS brief shortly. EJS is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.