Product code EJT: 510(k) clearances and predicates
Product code EJT covers PROMETAL HN86. FDA lists 627 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
627 clearances on file under product code EJT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest EJT clearances in the FDA index, with applicant and decision date:
- K052463, PROMETAL HN86, applicant Prometal Technologies, decided 2005-10-14. FDA record
- K041378, BIO 60, applicant Kodent, Inc., decided 2004-08-02. FDA record
- K040672, PORTA REFLEX, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2004-05-27. FDA record
- K040524, PORTA SOLDER 1090 W, applicant Wieland Dental + Technik GmbH & Co. KG, decided 2004-05-20. FDA record
- K040043, NDX-40 ALLOY, applicant Heraeus Kulzer, Inc., decided 2004-03-03. FDA record
- K034049, HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM, applicant Heraeus Kulzer,GmbH, decided 2004-03-01. FDA record
- K033279, GOLD DENTAL CASTING ALLOYS, applicant Bego U.S.A., decided 2004-01-15. FDA record
- K033446, APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82, applicant We Dong Myung Dental Industrial Co., Ltd., decided 2003-11-13. 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 BIO 60, PORTA REFLEX. Watch new EJT 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 EJT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EJT clearances include PROMETAL HN86.
How many 510(k) clearances use product code EJT?
627 at the time this page was generated, from openFDA records.
How do I find a predicate device under EJT?
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 EJT clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.