Product code EBG: 510(k) clearances and predicates
Product code EBG covers Dura-Arch. FDA lists 189 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
189 clearances on file under product code EBG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 so far | 2 |
Recent clearances
Newest EBG clearances in the FDA index, with applicant and decision date:
- K261261, Dura-Arch, applicant Hangzhou SHINING3D Dental Technology Co., Ltd., decided 2026-04-17. FDA record
- K253380, FLNT Base and FLNT Temp, applicant Liaoning Upcera Co., Ltd., decided 2026-03-02. FDA record
- K251271, TempFIT Temporary Crown and Bridge Resin, applicant Rizhao Huge Biomaterials Company, Ltd., decided 2025-06-23. FDA record
- K243370, DentaTOOTH, applicant Asiga Pty, Ltd., decided 2025-05-05. FDA record
- K243621, Evoblock, Perléon, applicant Evoden Indústria Comércio Importação E Exportação, decided 2025-04-22. FDA record
- K243951, TEMP MASTER, PMMA-based dental resin, applicant Taiwan Dental Materials Co., Ltd., decided 2025-02-21. FDA record
- K231859, PrimmaArt, applicant Dentscare Ltda, decided 2024-11-26. FDA record
- K242559, Digital Temp, applicant Sprintray, Inc., decided 2024-11-26. 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 FLNT Base and FLNT Temp, TempFIT Temporary Crown and Bridge Resin. Watch new EBG 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 EBG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EBG clearances include Dura-Arch.
How many 510(k) clearances use product code EBG?
189 at the time this page was generated, from openFDA records.
How do I find a predicate device under EBG?
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 EBG clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.