Product code EBI: 510(k) clearances and predicates
Product code EBI covers Glidewell™ Denture Base Resin. FDA lists 335 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
335 clearances on file under product code EBI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 11 |
| 2023 | 11 |
| 2024 | 9 |
| 2025 | 11 |
| 2026 so far | 7 |
Recent clearances
Newest EBI clearances in the FDA index, with applicant and decision date:
- K261802, Glidewell™ Denture Base Resin, applicant Prismatik Dentalcraft, Inc., decided 2026-08-27. FDA record
- K261626, UltraPrint Flexible Denture UV, applicant Guangzhou Heygears IMC., Inc., decided 2026-08-13. FDA record
- K262681, NanoCeram Resin, applicant 3BFAB TEKNOLOJI A.S., decided 2026-07-31. FDA record
- K262300, Denture Base Resin V2, applicant Formlabs Ohio, Inc., decided 2026-07-08. FDA record
- K261474, DENTCA Tru Flexible, applicant Dentca, Inc., decided 2026-07-01. FDA record
- K260569, DB 4000 High Impact Denture Base, applicant Carbon, Inc., decided 2026-06-02. FDA record
- K260376, Denture Base, applicant Shandong Huge Dental Material Corporation, decided 2026-05-06. FDA record
- K253365, LuxCreo Flexible Partial Denture Resin, applicant LuxCreo, Inc., decided 2025-11-25. 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 UltraPrint Flexible Denture UV, NanoCeram Resin. Watch new EBI 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 EBI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EBI clearances include Glidewell™ Denture Base Resin.
How many 510(k) clearances use product code EBI?
335 at the time this page was generated, from openFDA records.
How do I find a predicate device under EBI?
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 EBI clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.