Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EFB — Predicate Candidate Screening
261 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
339 days90th percentile
261clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | 252 | 0 |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | 252 | 0 |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 | 218 | 0 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W40 | Guangdong Jinme Medical Technology Co., Ltd. | 2024-11-13 | 282 | 0 |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, S | Foshan Soco Precision Instrument Co., Ltd. | 2024-11-12 | 207 | 0 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered | Nakanishi, Inc. | 2024-09-20 | 84 | 0 |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G | Litu Tech , Ltd. | 2024-04-30 | 216 | 0 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M20 | Nakanishi, Inc. | 2024-04-25 | 209 | 0 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 | 609 | 0 |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | 2023-08-23 | 26 | 0 |
| K230888 | Titanium Turbine | Nakanishi, Inc. | 2023-06-02 | 63 | 0 |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023-02-22 | 252 | 0 |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | 2022-12-12 | 818 | 0 |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbin | Shenzhen Carejoy Technology Co., Ltd. | 2022-11-17 | 430 | 0 |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-09-28 | 124 | 0 |
| K221814 | OK Handpiece | Jaintek Co.,Ltd | 2022-07-15 | 23 | 0 |
| K203791 | Stainless Turbine | Nakanishi, Inc. | 2022-06-21 | 540 | 0 |
| K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | 2021-11-08 | 446 | 0 |
| K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | 2021-09-03 | 346 | 0 |
| K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | 2020-08-11 | 259 | 0 |
| K181691 | High-speed air turbine handpiece / Low-speed air turbine han | Foshan Wenjian Medical Instrument Co., Ltd. | 2020-05-26 | 699 | 0 |
| K190509 | Lubrina 2 | J. Morita USA, Inc. | 2020-03-04 | 369 | 0 |
| K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona | 2020-01-13 | 131 | 0 |
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubri | Dentalez, Inc. | 2020-01-06 | 124 | 0 |
| K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | 2019-12-11 | 285 | 0 |
| K181900 | Dental high speed handpiece, Dental low speed handpiece | Foshan Cicada Dental Instrument Co, Ltd. | 2019-12-09 | 511 | 0 |
| K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH | 2019-04-10 | 348 | 0 |
| K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | 2018-07-24 | 210 | 0 |
| K172543 | High-speed Turbine Handpieces for Single Use | Beijing Dongbo Dental Handpiece Co., Ltd. | 2018-07-11 | 322 | 0 |
| K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. | 2018-03-28 | 140 | 0 |
| K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | 2017-12-18 | 241 | 0 |
| K171553 | W&H Assistina Twin | W&H Dentalwerk Buermoos GmbH | 2017-12-08 | 192 | 0 |
| K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-21 | 300 | 0 |
| K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-08 | 287 | 0 |
| K170261 | Premium Plus Prophy Air Motor | Premium Plus International Limited | 2017-10-19 | 265 | 0 |
| K163483 | PANA SPRAY Plus | Nakanishi, Inc. | 2017-08-15 | 246 | 0 |
| K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017-02-23 | 127 | 0 |
| K160410 | WOlf High Speed Handpieces - Medium head, WOlf High Speed Ha | Dental Savings Club | 2016-09-29 | 226 | 0 |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High | Dentalez, Inc. | 2016-04-08 | 135 | 0 |
| K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016-02-03 | 205 | 0 |
| K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-12-08 | 127 | 0 |
| K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015-11-23 | 329 | 0 |
| K141886 | MDK HANDPIECES | Modern Korea Co., Ltd. | 2015-05-13 | 303 | 0 |
| K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda | 2015-05-04 | 326 | 0 |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-04-24 | 29 | 0 |
| K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIE | Ttbio Corp. | 2015-02-27 | 296 | 0 |
| K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters | 2015-02-17 | 104 | 0 |
| K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES | Lares Research, Inc. | 2014-10-28 | 169 | 0 |
| K142063 | #8C RENEGADE DENTAL HANDPIECE | Handpiece Club, LLC | 2014-10-28 | 90 | 0 |
| K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | 2014-10-24 | 389 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda