EIA · Class I · 21 CFR 872.6640

FDA Product Code EIA: Unit, Operative Dental

FDA product code EIA covers operative dental units that integrate all components needed for dental treatment at a single patient chair.

These self-contained units combine delivery systems for air, water, suction, and instrument connections with an adjustable patient chair and operator's stool, providing the complete infrastructure for dental examination and treatment in a single integrated station.

EIA devices are Class I medical devices, regulated under 21 CFR 872.6640 and reviewed by the FDA Dental panel.

Leading manufacturers include A-Dec, Inc., Aseptico, Inc. and Ace Surgical Supply Co., Inc..

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
25–48 of 285
Cleared Dec 08, 2016
ESTETICA Dental Treatment Unit and Accessories
K161488
Kaltenbach & Voigt GmbH
Dental · 190d
Cleared Jan 22, 2016
TAURUS C1
K151996
Shinhung Company, Ltd.
Dental · 186d
Cleared Jan 22, 2016
Evogue Dental Unit
K152100
Takara Belmont Corporation
Dental · 178d
Cleared Sep 18, 2015
Spirit
K143696
Pelton & Crane
Dental · 268d
Cleared Jul 24, 2015
TENEO Dental Treatment Unit and Accessories
K151045
Sirona Dental Systems GmbH
Dental · 95d
Cleared Jul 17, 2015
INTEGO Family and Accesories
K150909
Sirona Dental Systems GmbH
Dental · 105d
Cleared Apr 17, 2015
UnicLine Mobile
K150490
Heka Dental A/S
Dental · 51d
Cleared Mar 13, 2015
Dental Unit
K142206
Zhuhai Siger Medical Equipment Co., Ltd.
Dental · 214d
Cleared Feb 24, 2015
T-8000 THEROZONE UNIT
K141504
Therozone USA, Inc.
Dental · 263d
Cleared Jan 08, 2015
S200, S300
K133412
Cefla S.C.
Dental · 427d
Cleared Sep 05, 2014
AJAX DENTAL UNIT
K132245
Pro Dental Services, LLC
Dental · 414d
Cleared Apr 18, 2014
ERGONOMIC PRODUCTS WORKSTATION
K132315
Ergonomic Products, Inc.
Dental · 267d
Cleared Oct 30, 2013
DIPLOMAT
K130534
Diplomat Dental S.R.O.
Dental · 243d
Cleared Jul 26, 2013
DENTAL UNIT WITH CHAIR
K130410
Xianyang North West Medical Instrument (Group) Co.
Dental · 157d
Cleared Aug 24, 2012
ELEVANCE
K120239
Midmark
Dental · 211d
Cleared Apr 05, 2012
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
K110481
Asi Medical, Inc.
Dental · 412d
Cleared Dec 02, 2011
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
K111907
Shanghai Dynamic Industry Co., Ltd.
Dental · 150d
Cleared Nov 10, 2011
CS 1200
K112321
Carestream Health, Inc.
Dental · 90d
Cleared Apr 11, 2011
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
K101332
Aseptico, Inc.
Dental · 334d
Cleared Jan 04, 2011
YOBOSHI DENTAL UNIT
K103550
Fosham Yoboshi Medical Equipment Co., Ltd.
Dental · 32d
Cleared Nov 24, 2010
A-DEC 200 DENTAL SYSTEM
K102234
A-Dec, Inc.
Dental · 107d
Cleared Jun 24, 2010
STERN'S S250 NORDAM
K092917
Cefla S.C.
Dental · 275d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186
Carestream Health, Inc.
Dental · 117d
Cleared Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
K082985
A-Dec, Inc.
Dental · 71d