Product code EFB: 510(k) clearances and predicates
Product code EFB covers DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece. FDA lists 262 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
262 clearances on file under product code EFB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 1 |
| 2026 so far | 3 |
Recent clearances
Newest EFB clearances in the FDA index, with applicant and decision date:
- K262144, DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece, applicant SETAGAYA SEIKI Co., Ltd., decided 2026-09-23. FDA record
- K251388, Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41), applicant Foshan Topmed Dental Co., Ltd., decided 2026-01-12. FDA record
- K251389, High speed air turbine handpiece, applicant Foshan Topmed Dental Co., Ltd., decided 2026-01-12. FDA record
- K242179, Synea Fusion Handpieces (Intensiv & Profin), applicant W&H Dentalwerk Bürmoos GmbH, decided 2025-02-28. FDA record
- K240337, Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L), applicant Guangdong Jinme Medical Technology Co., Ltd., decided 2024-11-13. FDA record
- K241074, High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M), applicant Foshan Soco Precision Instrument Co., Ltd., decided 2024-11-12. FDA record
- K241880, Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip), applicant Nakanishi, Inc., decided 2024-09-20. FDA record
- K233122, High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L), applicant Litu Tech , Ltd., decided 2024-04-30. 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 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41), High speed air turbine handpiece. Watch new EFB 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 EFB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent EFB clearances include DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece.
How many 510(k) clearances use product code EFB?
262 at the time this page was generated, from openFDA records.
How do I find a predicate device under EFB?
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 EFB clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for EFB, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free EFB brief
Tell us where to send it. No card required.
You are on the list.
We will email your free EFB brief shortly. EFB is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.