Unit, Operative Dental
Regulation 872.6640
2510(k)s in 12 months (286 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EIA
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 25 | 0 |
| Pelton & Crane | 5 | 1 |
| Planmeca Oy | 6 | 0 |
| Aseptico, Inc. | 5 | 0 |
| Ace Surgical Supply Co., Inc. | 4 | 0 |
| Air Techniques, Inc. | 4 | 0 |
| Asi Medical, Inc. | 3 | 1 |
| Scitech Solutions, Inc. | 4 | 0 |
| Sds Dental, Inc. | 4 | 0 |
| Sirona Dental Systems GmbH | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) Guangdong JINME Medical Technology Co., Ltd., CN | EIA |
| Aug 7, 2026 | K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) Lakong Medical Devices Co., Ltd., CN | EIA |
| Nov 3, 2025 | K251626 | Midmark Dental Delivery System Midmark Corporation | EIA |
| Jul 17, 2025 | K251491 | K5 Cart, K5 Mount, K5 Swing Osstem Implant Company., Ltd. Chair Business, KR | EIA |
| Jun 27, 2025 | K243130 | Integral Dental Unit Guangdong Yadeng Medical Apparatus Co., Ltd.,, CN | EIA |
| May 27, 2025 | K242611 | Integral Dental Units Mipont Medical Equipment Co., Ltd., CN | EIA |
| Feb 19, 2025 | K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus Dci International, LLC | EIA |
| Feb 7, 2025 | K242404 | BDC Dental Unit Bdc Dental Corporation , Ltd., CN | EIA |
| Jan 27, 2025 | K231297 | Firstar Dental Unit Firstar Dental Company | EIA |
| Sep 3, 2024 | K233805 | K5 Osstem Implant Co., Ltd. Chair Business, KR | EIA |
| Mar 21, 2024 | K240754 | N2 Megagen Implant Co., Ltd., KR | EIA |
| Feb 28, 2024 | K231845 | Dental unit Model: Mare Foshan Safety Medical Equipment Co., Ltd., CN | EIA |
| May 5, 2023 | K202963 | ELEC Master, ELEC Master Dual Mgnewton , Ltd., KR | EIA |
| Apr 5, 2023 | K211556 | N2 Megagen Implant Co., Ltd., KR | EIA |
| Apr 3, 2023 | K213749 | G7, Dental Operative Unit and Accessories Shinhung Company, Ltd., KR | EIA |
| Dec 15, 2022 | K220873 | Perceptive electric dental motor and control unit Lares Research | EIA |
| Oct 19, 2022 | K213742 | Infinity Pro, Logic, Quality, Sprint Olsen Indústria E Comércio S.A., BR | EIA |
| Mar 2, 2022 | K213932 | A-dec 300, A-dec 500 A-Dec, Inc. | EIA |
| Feb 5, 2020 | K180935 | Infinity / Infinity Cross Flex Dental Systems Olsen Industria E Comercio S.A., BR | EIA |
| Sep 4, 2019 | K183347 | K3 Osstem Implant Co., Ltd., KR | EIA |
| Jul 18, 2019 | K183121 | Qraypen AIOBIO Co., Ltd., KR | EIA |
| Aug 17, 2018 | K173608 | Forest Dental Unit Forest Dental Products, Inc. | EIA |
| Apr 26, 2018 | K171872 | P50 Series Dental Operative Unit and Accessories Pelton & Crane | EIA |
| Apr 20, 2017 | K152830 | K3 Osstem Implant Co., Ltd., KR | EIA |
| Dec 9, 2016 | K161734 | Vanguard Dental Unit Ritter Concept GmbH, DE | EIA |
| Dec 8, 2016 | K161488 | ESTETICA Dental Treatment Unit and Accessories Kaltenbach & Voigt GmbH, DE | EIA |
| Jan 22, 2016 | K152100 | Evogue Dental Unit Takara Belmont Corporation, JP | EIA |
| Jan 22, 2016 | K151996 | TAURUS C1 Shinhung Company, Ltd., KR | EIA |
| Sep 18, 2015 | K143696 | Spirit Pelton & Crane | EIA |
| Jul 24, 2015 | K151045 | TENEO Dental Treatment Unit and Accessories Sirona Dental Systems GmbH, DE | EIA |
| Jul 17, 2015 | K150909 | INTEGO Family and Accesories Sirona Dental Systems GmbH, DE | EIA |
| Apr 17, 2015 | K150490 | UnicLine Mobile Heka Dental A/S, DK | EIA |
| Mar 13, 2015 | K142206 | Dental Unit Zhuhai Siger Medical Equipment Co., Ltd., CN | EIA |
| Feb 24, 2015 | K141504 | T-8000 THEROZONE UNIT Therozone USA, Inc. | EIA |
| Jan 8, 2015 | K133412 | S200, S300 Cefla S.C. | EIA |
| Sep 5, 2014 | K132245 | AJAX DENTAL UNIT Pro Dental Services, LLC | EIA |
| Apr 18, 2014 | K132315 | ERGONOMIC PRODUCTS WORKSTATION Ergonomic Products, Inc. | EIA |
| Oct 30, 2013 | K130534 | DIPLOMAT Diplomat Dental S.R.O. | EIA |
| Jul 26, 2013 | K130410 | DENTAL UNIT WITH CHAIR Xianyang North West Medical Instrument (Group) Co., CN | EIA |
| Aug 24, 2012 | K120239 | ELEVANCE Midmark | EIA |
| Apr 5, 2012 | K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE Asi Medical, Inc. | EIA |
| Dec 2, 2011 | K111907 | DYNAMIC DU SERIES PORTABLE DENTAL UNIT Shanghai Dynamic Industry Co., Ltd., CN | EIA |
| Nov 10, 2011 | K112321 | CS 1200 Carestream Health, Inc. | EIA |
| Apr 11, 2011 | K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 Aseptico, Inc. | EIA |
| Feb 25, 2011 | K102223 | CHALLENGE-EVER Hallim Dentech Co., Ltd. | EIA |
| Jan 4, 2011 | K103550 | YOBOSHI DENTAL UNIT Fosham Yoboshi Medical Equipment Co., Ltd., CN | EIA |
| Nov 24, 2010 | K102234 | A-DEC 200 DENTAL SYSTEM A-Dec, Inc. | EIA |
| Oct 22, 2010 | K100212 | DENTACENTER/EXPEDITION, MODEL SAF-430 Safari Dental, Inc., CA | EIA |
| Jun 24, 2010 | K092917 | STERN'S S250 NORDAM Cefla S.C. | EIA |
| Sep 29, 2009 | K092851 | MODEL GDCH-2000 Global Dental Direct, Inc., CA | EIA |
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