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