Product code EIA: 510(k) clearances and predicates
Product code EIA covers Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0). FDA lists 285 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
285 clearances on file under product code EIA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 7 |
| 2026 so far | 1 |
Recent clearances
Newest EIA clearances in the FDA index, with applicant and decision date:
- K251544, Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0), applicant Lakong Medical Devices Co., Ltd., decided 2026-08-07. FDA record
- K251626, Midmark Dental Delivery System, applicant Midmark Corporation, decided 2025-11-03. FDA record
- K251491, K5 Cart, K5 Mount, K5 Swing, applicant Osstem Implant Company., Ltd. Chair Business, decided 2025-07-17. FDA record
- K243130, Integral Dental Unit, applicant Guangdong Yadeng Medical Apparatus Co., Ltd.,, decided 2025-06-27. FDA record
- K242611, Integral Dental Units, applicant Mipont Medical Equipment Co., Ltd., decided 2025-05-27. FDA record
- K250473, Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus, applicant Dci International, LLC, decided 2025-02-19. FDA record
- K242404, BDC Dental Unit, applicant Bdc Dental Corporation , Ltd., decided 2025-02-07. FDA record
- K231297, Firstar Dental Unit, applicant Firstar Dental Company, decided 2025-01-27. 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 Midmark Dental Delivery System, K5 Cart, K5 Mount, K5 Swing. Watch new EIA 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 EIA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EIA clearances include Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0).
How many 510(k) clearances use product code EIA?
285 at the time this page was generated, from openFDA records.
How do I find a predicate device under EIA?
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 EIA 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.