Product code EBF: 510(k) clearances and predicates
Product code EBF covers Core·it Dual. FDA lists 937 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
937 clearances on file under product code EBF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 17 |
| 2023 | 9 |
| 2024 | 18 |
| 2025 | 15 |
| 2026 so far | 17 |
Recent clearances
Newest EBF clearances in the FDA index, with applicant and decision date:
- K262982, Core·it Dual, applicant Spident Co., Ltd., decided 2026-09-21. FDA record
- K262202, Cerasmart Forte, applicant GC America, Inc., decided 2026-09-10. FDA record
- K261695, Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF), applicant Guilin Kevin Peter Technology Co., Ltd., decided 2026-08-31. FDA record
- K262228, Transcend Bulk Fill Flowable Composite, applicant Ultradent Products, Inc., decided 2026-07-01. FDA record
- K261485, Tetric plus Fill;Tetric plus Flow, applicant Ivoclar Vivadent, Inc., decided 2026-07-01. FDA record
- K261246, SRGC-06, applicant GC America, Inc., decided 2026-06-18. FDA record
- K261093, DIAFIL, applicant DiaDent Group International, decided 2026-06-02. FDA record
- K261071, DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g), applicant DiaDent Group International, decided 2026-05-19. 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 Cerasmart Forte, Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF). Watch new EBF 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 EBF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EBF clearances include Core·it Dual.
How many 510(k) clearances use product code EBF?
937 at the time this page was generated, from openFDA records.
How do I find a predicate device under EBF?
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 EBF clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.