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EIA

285 FDA 510(k) clearances · Product code

89 daysmedian time to decision
301 days90th percentile
285clearances measured

FDA profile

Official device name
Unit, Operative Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 49 · 2022: 44 · 2023: 53 · 2024: 53 · 2025: 47 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) (K251544)Lakong Medical Devices Co., Ltd.2026-08-07
Midmark Dental Delivery System (K251626)Midmark Corporation2025-11-03
K5 Cart, K5 Mount, K5 Swing (K251491)Osstem Implant Company., Ltd. Chair Business2025-07-17
Integral Dental Unit (K243130)Guangdong Yadeng Medical Apparatus Co., Ltd.,2025-06-27
Integral Dental Units (K242611)Mipont Medical Equipment Co., Ltd.2025-05-27
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (K250473)Dci International, LLC2025-02-19
BDC Dental Unit (K242404)Bdc Dental Corporation , Ltd.2025-02-07
Firstar Dental Unit (K231297)Firstar Dental Company2025-01-27
K5 (K233805)Osstem Implant Co., Ltd. Chair Business2024-09-03
N2 (K240754)Megagen Implant Co., Ltd.2024-03-21
Dental unit Model: Mare (K231845)Foshan Safety Medical Equipment Co., Ltd.2024-02-28
ELEC Master, ELEC Master Dual (K202963)Mgnewton , Ltd.2023-05-05
N2 (K211556)Megagen Implant Co., Ltd.2023-04-05
G7, Dental Operative Unit and Accessories (K213749)Shinhung Company, Ltd.2023-04-03
Perceptive electric dental motor and control unit (K220873)Lares Research2022-12-15
Infinity Pro, Logic, Quality, Sprint (K213742)Olsen Indústria E Comércio S.A.2022-10-19
A-dec 300, A-dec 500 (K213932)A-Dec, Inc.2022-03-02
Infinity / Infinity Cross Flex Dental Systems (K180935)Olsen Industria E Comercio S.A.2020-02-05
K3 (K183347)Osstem Implant Co., Ltd.2019-09-04
Qraypen (K183121)AIOBIO Co., Ltd.2019-07-18
Forest Dental Unit (K173608)Forest Dental Products, Inc.2018-08-17
P50 Series Dental Operative Unit and Accessories (K171872)Pelton & Crane2018-04-26
K3 (K152830)Osstem Implant Co., Ltd.2017-04-20
Vanguard Dental Unit (K161734)Ritter Concept GmbH2016-12-09
ESTETICA Dental Treatment Unit and Accessories (K161488)Kaltenbach & Voigt GmbH2016-12-08
Evogue Dental Unit (K152100)Takara Belmont Corporation2016-01-22
TAURUS C1 (K151996)Shinhung Company, Ltd.2016-01-22
Spirit (K143696)Pelton & Crane2015-09-18
TENEO Dental Treatment Unit and Accessories (K151045)Sirona Dental Systems GmbH2015-07-24
INTEGO Family and Accesories (K150909)Sirona Dental Systems GmbH2015-07-17
UnicLine Mobile (K150490)Heka Dental A/S2015-04-17
Dental Unit (K142206)Zhuhai Siger Medical Equipment Co., Ltd.2015-03-13
T-8000 THEROZONE UNIT (K141504)Therozone USA, Inc.2015-02-24
S200, S300 (K133412)Cefla S.C.2015-01-08
AJAX DENTAL UNIT (K132245)Pro Dental Services, LLC2014-09-05
ERGONOMIC PRODUCTS WORKSTATION (K132315)Ergonomic Products, Inc.2014-04-18
DIPLOMAT (K130534)Diplomat Dental S.R.O.2013-10-30
DENTAL UNIT WITH CHAIR (K130410)Xianyang North West Medical Instrument (Group) Co.2013-07-26
ELEVANCE (K120239)Midmark2012-08-24
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE (K110481)Asi Medical, Inc.2012-04-05
DYNAMIC DU SERIES PORTABLE DENTAL UNIT (K111907)Shanghai Dynamic Industry Co., Ltd.2011-12-02
CS 1200 (K112321)Carestream Health, Inc.2011-11-10
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (K101332)Aseptico, Inc.2011-04-11
CHALLENGE-EVER (K102223)Hallim Dentech Co., Ltd.2011-02-25
YOBOSHI DENTAL UNIT (K103550)Fosham Yoboshi Medical Equipment Co., Ltd.2011-01-04
A-DEC 200 DENTAL SYSTEM (K102234)A-Dec, Inc.2010-11-24
DENTACENTER/EXPEDITION, MODEL SAF-430 (K100212)Safari Dental, Inc.2010-10-22
STERN'S S250 NORDAM (K092917)Cefla S.C.2010-06-24
MODEL GDCH-2000 (K092851)Global Dental Direct, Inc.2009-09-29
KODAK 1500 INTRAORAL CAMERA (K091186)Carestream Health, Inc.2009-08-18
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 (K090079)Progeny, Inc.2009-05-01
A-DEC 334/335 DELIVERY SYSTEM (K082985)A-Dec, Inc.2008-12-17
PLANMECA SOVEREIGN (K081699)Planmeca USA, Inc.2008-08-29
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT (K081237)Craftmaster Contour Equipment, Inc.2008-08-25
WESTAR SERIES DENTAL UNITS (K082294)Westar Medical Products, Inc.2008-08-22
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE (K080677)Kaltenbach & Voigt GmbH & Co.2008-06-06
DENTAL UNIT WITH CHAIR (K080438)North West Medical Instrument (Group) Co., Ltd.2008-04-04
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 (K071485)Tpc Advanced Technology, Inc.2007-08-28
OPTI (K063646)Camsight Co., Inc.2007-03-07
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT (K070196)Hr Dental Products, Inc.2007-01-26
C-U2 (K062897)Cefla S.C.R.L.2006-12-14
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES (K063302)Shanghai Dental Instrument Factory2006-11-15
COMPACT PLUS - EXTREME - PERFECT PLUS (K052574)J.O. Suarez & Cia, Ltda2006-07-17
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES (K061175)Sota Precision Optics, Inc.2006-05-23
ABSOLUTE AMERICA (K050571)Eurodent S.P.A.2005-11-02
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT (K052470)Shanghai Fimet Medical Instrument Co., Ltd.2005-11-01
A-DEC SELF-CONTAINED WATER SYSTEM (K051657)A-Dec, Inc.2005-08-30
AEU-14CF EXPENDITION (K050201)Aseptico, Inc.2005-03-18
SPACELINE EMCIA, MODEL CU580 (K043496)J. Morita USA, Inc.2005-02-16
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES (K043325)Rolence Enteprise, Inc.2005-02-11
OPTIMA MX (K042759)Bien-Air SA Switzerland2004-10-20
MICROSCOPE SYSTEM (K041805)Miras Mirror Imaging Solutions, Ltd.2004-09-21
MARE DENTAL OPERATIVE UNIT (K041458)Denimed Electronica S.H.2004-08-24
COCOON HYGIENIST (K040529)Satelec2004-08-19
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT (K040117)Arrow Industries, LLC2004-04-21
HAWK INTRAORAL CAMERA AND ACCESSORIES (K040116)Dxm Co., Ltd.2004-04-20
BIOFREE (K033925)Dental Components, Inc.2004-04-07
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D (K040691)Win-Us Technology Co., Ltd.2004-03-23
STV PRO 2 (K033419)Trophy Radiologie2004-02-02
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (K032757)A-Dec, Inc.2003-12-10
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (K032756)A-Dec, Inc.2003-12-04
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES (K032543)Sirona Dental Systems GmbH2003-11-14
STERISIL ANTIMICROBIAL TUBING AND BOTTLE (K031681)Sterisil2003-10-30
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 (K032904)Dentsply Intl.2003-10-14
ELCACAM (K032070)A-Dec, Inc.2003-08-27
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 (K032341)Sota Precision Optics, Inc.2003-08-25
C-1890 (K023896)Anodia Systems2003-06-19
C-1805M (K023815)Anodia Systems2003-06-19
LOGOS JUNIOR DENTAL CHAIR AND UNIT (K023513)Castellini S.P.A.2003-03-26
RDH-2000 (K023213)Anodia Systems2003-01-16
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM (K022217)Aseptico, Inc.2002-10-24
VERACAM (K021083)Lumalite, Inc.2002-08-30
BOYD DELIVERY UNIT (K020833)Boyd Industries, Inc.2002-08-08
ORACAM (K020957)Video Dental Concepts, Inc.2002-06-13
INTRAORAL CAMERA ME-15 (K020206)Dent Corp. Research & Development2002-04-11
IDENT-A100 INTRAORAL VIDEO CAMERA (K013690)Confident Technology, Inc.2002-01-30
INTRAORAL LENS OPTION TO SPECTROSHADE (K012744)Mht Optic Research AG2002-01-23
SOPRO595 INTRA ORAL CAMERA (K012505)Sopro2001-10-05
GULLIVER AND CLASSE A (K012213)American Dental Technologies, Inc.2001-08-13
PORTABELL, MODEL 4200 (K011222)Bell Dental Products, LLC2001-06-25
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