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 Air Techniques, Inc..

286
Total
286
Cleared
141d
Avg days
1977
Since
286 devices
25–48 of 286
Cleared Dec 09, 2016
Vanguard Dental Unit
K161734
Ritter Concept GmbH
Dental · 169d
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 Feb 25, 2011
CHALLENGE-EVER
K102223
Hallim Dentech Co., Ltd.
Dental · 203d
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 Oct 22, 2010
DENTACENTER/EXPEDITION, MODEL SAF-430
K100212
Safari Dental, Inc.
Dental · 270d