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..

285
Total
285
Cleared
141d
Avg days
1977
Since
285 devices
97–120 of 285
Cleared Nov 04, 1998
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
K983285
Engle Dental Systems
Dental · 47d
Cleared Oct 15, 1998
BIOCLEAR CONCENTRATE
K981565
Waggoner Product Development
Dental · 167d
Cleared Oct 15, 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658
KARL STORZ Endoscopy-America, Inc.
Dental · 77d
Cleared Oct 08, 1998
ULTRACAM
K973410
W. Edward Johansen
Dental · 394d
Cleared Sep 15, 1998
CLEAN SOURCE I, MODEL CS1000
K981144
Aquarius Technologies, Inc.
Dental · 169d
Cleared Sep 15, 1998
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
K982480
Dentalview, Inc.
Dental · 61d
Cleared Sep 04, 1998
FLUID CONTROL
K982117
T.A. Coleman Ent.
Dental · 80d
Cleared Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937
Welch Allyn, Inc.
Dental · 83d
Cleared Aug 11, 1998
BONETRAP
K980049
Bladhs Plast AB
Dental · 217d
Cleared Aug 10, 1998
DIGITAL DOC
K981663
Digital Doc, LLC
Dental · 91d
Cleared Aug 03, 1998
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
K980106
Proma, Inc.
Dental · 203d
Cleared Jul 23, 1998
VIPERCAM
K981534
Integra Medical
Dental · 85d
Cleared Jun 25, 1998
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K982009
Scitech Solutions, Inc.
Dental · 84d
Cleared May 08, 1998
PRINCESS SYRINGE
K980577
Sodexco
Dental · 80d
Cleared Apr 13, 1998
TELICAM
K980474
Dental/Medical Diagnostic Systems, Inc.
Dental · 66d
Cleared Feb 18, 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
K974487
Asi Medical, Inc.
Dental · 84d
Cleared Feb 17, 1998
TRUE VISION, TRUE VISION II
K974542
Medical Dynamics, Inc.
Dental · 76d
Cleared Feb 04, 1998
CLEARLINE PLUS, DENTAL WATERLINE FILTER
K973996
Scitech Solutions, Inc.
Dental · 106d
Cleared Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238
Trinity Laboratories, Inc.
Dental · 84d
Cleared Jan 08, 1998
VISTACAM OMNI AND VIASTCAM OMNI (IC)
K974204
Air Techniques, Inc.
Dental · 59d
Cleared Dec 19, 1997
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
K964271
Airel-West
Dental · 420d
Cleared Oct 21, 1997
DENTALVIEW PERIOVIEW SYSTEM
K973492
Dentalview, Inc.
Dental · 36d
Cleared Sep 24, 1997
VIOLA II DENTAL CAMERA SYSTEM
K973035
Innovative Medical Systems, Inc.
Dental · 41d
Cleared Sep 12, 1997
DCI WATER PURIFIER
K971727
Dental Components, Inc.
Dental · 126d