Product code EBZ: 510(k) clearances and predicates
Product code EBZ covers Curing Light (M-Cure 6). FDA lists 214 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
214 clearances on file under product code EBZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 so far | 1 |
Recent clearances
Newest EBZ clearances in the FDA index, with applicant and decision date:
- K253131, Curing Light (M-Cure 6), applicant Guangzhou Rebornendo Medical Instrument Co., Ltd., decided 2026-06-18. FDA record
- K253461, Demi Pro, applicant Meta Systems Co., Ltd., decided 2025-10-14. FDA record
- K242386, Bluemoon, applicant Genoss Co., Ltd., decided 2025-05-05. FDA record
- K243921, LED Curing Lights (DB686 HALO), applicant Foshan Coxo Medical Instrument Co., Ltd., decided 2025-04-11. FDA record
- K250009, LED Curing Light (C01-X, C02-X), applicant Premium Plus (Dongguan) Limited, decided 2025-04-10. FDA record
- K241238, LOOP™ LED Curing Light System (CLK01), applicant Garrison Dental Solutions, LLC, decided 2024-08-01. FDA record
- K223414, Curing Light, Model: MaxCure 9, applicant Guilin Refine Medical Instrument Co., Ltd., decided 2023-11-15. FDA record
- K233518, BASE290 LED Curing Light, applicant Handpiece Headquarters, decided 2023-11-02. 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 Demi Pro, Bluemoon. Watch new EBZ 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 EBZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EBZ clearances include Curing Light (M-Cure 6).
How many 510(k) clearances use product code EBZ?
214 at the time this page was generated, from openFDA records.
How do I find a predicate device under EBZ?
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 EBZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.