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 Sds Dental, Inc..

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
73–96 of 285
Cleared Sep 07, 1999
DENTAPURE DP40 CARTRIDGE
K992868
Mrlb Intl., Inc.
Dental · 12d
Cleared Sep 03, 1999
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
K991946
Sterilex Corp.
Dental · 86d
Cleared Jun 30, 1999
DIFOTI SYSTEM
K991098
Electro-Optical Sciences, Inc.
Dental · 90d
Cleared Jun 24, 1999
QUANTEC-E IRRIGATION SYSTEM
K991035
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Jun 23, 1999
ORASCOPE
K991011
Fiberdent Corp.
Dental · 89d
Cleared May 28, 1999
STARDENTAL AXCS STERILE WATER SYSTEM
K990844
Dentalez Group
Dental · 74d
Cleared May 13, 1999
HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
K990479
Hygenitek, Inc.
Dental · 86d
Cleared Apr 29, 1999
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,
K984332
International Technology Concepts
Dental · 147d
Cleared Apr 29, 1999
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
K991161
Kay See Dental Mfg. Co.
Dental · 22d
Cleared Apr 21, 1999
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948
Sopro
Dental · 30d
Cleared Mar 29, 1999
FLEXISCOPE OPTOMODUL
K984641
Schoelly Fiberoptic GmbH
Dental · 88d
Cleared Mar 22, 1999
AIR TECHNIQUES' DENTO-VAC
K984584
Air Techniques, Inc.
Dental · 88d
Cleared Feb 09, 1999
SCICAN CLASSIC
K984556
Scholly Fiberoptic GmbH
Dental · 48d
Cleared Feb 09, 1999
ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III
K984609
Lite Specialty Metal Works, Inc.
Dental · 43d
Cleared Jan 26, 1999
PLANMECA INTRACAM STATION
K984013
Planmeca Oy
Dental · 76d
Cleared Jan 19, 1999
OPTUM, INTRAORAL CAMERA SYSTEM
K983739
Camsight, Inc.
Dental · 89d
Cleared Jan 12, 1999
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661
Belmont Equipment Corp.
Dental · 85d
Cleared Jan 11, 1999
S555 INTRAORAL DENTAL CAMERA
K983625
Sopro
Dental · 88d
Cleared Jan 07, 1999
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
K983735
Pall Medical
Dental · 77d
Cleared Dec 21, 1998
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
K983731
Pall Medical
Dental · 60d
Cleared Dec 11, 1998
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242
Sirona Dental Systems GmbH
Dental · 86d
Cleared Dec 02, 1998
ERADIC-ALL
K981171
Theratechnologies, Inc.
Dental · 245d
Cleared Dec 01, 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847
Germiphene Corp.
Dental · 32d
Cleared Nov 04, 1998
BIO-2000
K973765
Micrylium Laboratories
Dental · 398d