Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIA — Predicate Candidate Screening
285 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
301 days90th percentile
285clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 | 444 | 0 |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 | 159 | 0 |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 | 64 | 0 |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 | 270 | 0 |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025-05-27 | 266 | 0 |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System S | Dci International, LLC | 2025-02-19 | 0 | 0 |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | 2025-02-07 | 178 | 0 |
| K231297 | Firstar Dental Unit | Firstar Dental Company | 2025-01-27 | 634 | 0 |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024-09-03 | 279 | 0 |
| K240754 | N2 | Megagen Implant Co., Ltd. | 2024-03-21 | 1 | 0 |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024-02-28 | 251 | 0 |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | 2023-05-05 | 947 | 0 |
| K211556 | N2 | Megagen Implant Co., Ltd. | 2023-04-05 | 686 | 0 |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | 2023-04-03 | 489 | 0 |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | 2022-12-15 | 265 | 0 |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | 2022-10-19 | 324 | 0 |
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | 2022-03-02 | 76 | 0 |
| K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | 2020-02-05 | 666 | 0 |
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019-09-04 | 275 | 0 |
| K183121 | Qraypen | AIOBIO Co., Ltd. | 2019-07-18 | 251 | 0 |
| K173608 | Forest Dental Unit | Forest Dental Products, Inc. | 2018-08-17 | 269 | 0 |
| K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane | 2018-04-26 | 307 | 0 |
| K152830 | K3 | Osstem Implant Co., Ltd. | 2017-04-20 | 569 | 0 |
| K161734 | Vanguard Dental Unit | Ritter Concept GmbH | 2016-12-09 | 169 | 0 |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016-12-08 | 190 | 0 |
| K152100 | Evogue Dental Unit | Takara Belmont Corporation | 2016-01-22 | 178 | 0 |
| K151996 | TAURUS C1 | Shinhung Company, Ltd. | 2016-01-22 | 186 | 0 |
| K143696 | Spirit | Pelton & Crane | 2015-09-18 | 268 | 0 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015-07-24 | 95 | 0 |
| K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | 2015-07-17 | 105 | 0 |
| K150490 | UnicLine Mobile | Heka Dental A/S | 2015-04-17 | 51 | 0 |
| K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | 2015-03-13 | 214 | 0 |
| K141504 | T-8000 THEROZONE UNIT | Therozone USA, Inc. | 2015-02-24 | 263 | 0 |
| K133412 | S200, S300 | Cefla S.C. | 2015-01-08 | 427 | 0 |
| K132245 | AJAX DENTAL UNIT | Pro Dental Services, LLC | 2014-09-05 | 414 | 0 |
| K132315 | ERGONOMIC PRODUCTS WORKSTATION | Ergonomic Products, Inc. | 2014-04-18 | 267 | 0 |
| K130534 | DIPLOMAT | Diplomat Dental S.R.O. | 2013-10-30 | 243 | 0 |
| K130410 | DENTAL UNIT WITH CHAIR | Xianyang North West Medical Instrument (Group) Co. | 2013-07-26 | 157 | 0 |
| K120239 | ELEVANCE | Midmark | 2012-08-24 | 211 | 0 |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED D | Asi Medical, Inc. | 2012-04-05 | 412 | 0 |
| K111907 | DYNAMIC DU SERIES PORTABLE DENTAL UNIT | Shanghai Dynamic Industry Co., Ltd. | 2011-12-02 | 150 | 0 |
| K112321 | CS 1200 | Carestream Health, Inc. | 2011-11-10 | 90 | 0 |
| K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | Aseptico, Inc. | 2011-04-11 | 334 | 0 |
| K102223 | CHALLENGE-EVER | Hallim Dentech Co., Ltd. | 2011-02-25 | 203 | 0 |
| K103550 | YOBOSHI DENTAL UNIT | Fosham Yoboshi Medical Equipment Co., Ltd. | 2011-01-04 | 32 | 0 |
| K102234 | A-DEC 200 DENTAL SYSTEM | A-Dec, Inc. | 2010-11-24 | 107 | 0 |
| K100212 | DENTACENTER/EXPEDITION, MODEL SAF-430 | Safari Dental, Inc. | 2010-10-22 | 270 | 0 |
| K092917 | STERN'S S250 NORDAM | Cefla S.C. | 2010-06-24 | 275 | 0 |
| K092851 | MODEL GDCH-2000 | Global Dental Direct, Inc. | 2009-09-29 | 13 | 0 |
| K091186 | KODAK 1500 INTRAORAL CAMERA | Carestream Health, Inc. | 2009-08-18 | 117 | 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