FDA product code · Dental
EFBHandpiece, Air-Powered, Dental
Product code EFB covers Handpiece, Air-Powered, Dental, a Class I device regulated under 21 CFR 872.4200. FDA has cleared 261 devices in this code, 2 of them in the last 12 months. Median review time across the 261 most recent decisions is 104 days. openFDA lists 8 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 872.4200
- Review panel
- Dental
- Clearances
- 261
What is happening in EFB right now?
EFB (Handpiece, Air-Powered, Dental) has two findings, most consequential first. 1 first-time filer in the last 12 months, Foshan Topmed Dental Co., Ltd (K251388). The code is crowded, scoring 71 of 100 — 140 companies hold a clearance here and 2 arrived in the last 12 months (EFB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K251388 |
| Crowding | Context | EFB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in EFB?
FDA has cleared 261 devices under product code EFB since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | |
| 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) | Foshan Topmed Dental Co., Ltd. | |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | |
| 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) | Foshan Soco Precision Instrument Co., Ltd. | |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. |
How long does FDA review take for EFB?
The median FDA review time for EFB is 104 days, measured across the 261 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EFB?
openFDA lists 8 recall records against product code EFB. A recall record covers one firm's corrective action and may span many device lots.
Z-1208-2023Open, ClassifiedColtene /Whaledent AG
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Z-2674-2016TerminatedNakanishi Inc.
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
Z-2044-2014TerminatedMTI Precision Products LLC.
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
Z-0289-2007TerminatedKavo America Corporation
The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
Z-0154-04TerminatedDentSply -Professional Division
Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
Showing the 5 most recently initiated of 8. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EFB?
MAUDE holds 312 adverse-event reports naming product code EFB, 44 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EFB unusual?
Every month with enough history behind it falls inside EFB's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 30 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 13 | 0–17 | Within expected (0–17) | |
| 1 | 0–17 | Within expected (0–17) | |
| 1 | 0–17 | Within expected (0–17) | |
| 15 | 0–17 | Within expected (0–17) | |
| 3 | 0–18 | Within expected (0–18) | |
| 2 | 0–18 | Within expected (0–18) | |
| 20 | 0–27 | Within expected (0–27) | |
| 1 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history |
28 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in EFB.
Who has entered EFB in the last year?
One company filed in EFB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Foshan Topmed Dental Co., Ltd. | K251388 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in EFB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EFB?
Across the 261 most recent decisions, these applicants filed most often in EFB.
| Applicant | Recent clearances |
|---|---|
| A-Dec, Inc. | 19 |
| Nakanishi, Inc. | 10 |
| Dentsply Intl. | 7 |
| Micro Motors, Inc. | 7 |
| Dentalez, Inc. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in EFB files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Dentsply Intl., Inc. | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch EFB
Get an email the morning anything changes in EFB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.