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..
285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
Cleared
Nov 04, 1998
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
Engle Dental Systems
Dental
47d
Cleared
Oct 15, 1998
BIOCLEAR CONCENTRATE
Waggoner Product Development
Dental
167d
Cleared
Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
KARL STORZ Endoscopy-America, Inc.
Dental
77d
Cleared
Oct 08, 1998
ULTRACAM
W. Edward Johansen
Dental
394d
Cleared
Sep 15, 1998
CLEAN SOURCE I, MODEL CS1000
Aquarius Technologies, Inc.
Dental
169d
Cleared
Sep 15, 1998
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
Dentalview, Inc.
Dental
61d
Cleared
Sep 04, 1998
FLUID CONTROL
T.A. Coleman Ent.
Dental
80d
Cleared
Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
Welch Allyn, Inc.
Dental
83d
Cleared
Aug 11, 1998
BONETRAP
Bladhs Plast AB
Dental
217d
Cleared
Aug 10, 1998
DIGITAL DOC
Digital Doc, LLC
Dental
91d
Cleared
Aug 03, 1998
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
Proma, Inc.
Dental
203d
Cleared
Jul 23, 1998
VIPERCAM
Integra Medical
Dental
85d
Cleared
Jun 25, 1998
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
Scitech Solutions, Inc.
Dental
84d
Cleared
May 08, 1998
PRINCESS SYRINGE
Sodexco
Dental
80d
Cleared
Apr 13, 1998
TELICAM
Dental/Medical Diagnostic Systems, Inc.
Dental
66d
Cleared
Feb 18, 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
Asi Medical, Inc.
Dental
84d
Cleared
Feb 17, 1998
TRUE VISION, TRUE VISION II
Medical Dynamics, Inc.
Dental
76d
Cleared
Feb 04, 1998
CLEARLINE PLUS, DENTAL WATERLINE FILTER
Scitech Solutions, Inc.
Dental
106d
Cleared
Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
Trinity Laboratories, Inc.
Dental
84d
Cleared
Jan 08, 1998
VISTACAM OMNI AND VIASTCAM OMNI (IC)
Air Techniques, Inc.
Dental
59d
Cleared
Dec 19, 1997
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
Airel-West
Dental
420d
Cleared
Oct 21, 1997
DENTALVIEW PERIOVIEW SYSTEM
Dentalview, Inc.
Dental
36d
Cleared
Sep 24, 1997
VIOLA II DENTAL CAMERA SYSTEM
Innovative Medical Systems, Inc.
Dental
41d
Cleared
Sep 12, 1997
DCI WATER PURIFIER
Dental Components, Inc.
Dental
126d