EFS · Class I · 21 CFR 872.6510

FDA Product Code EFS: Unit, Oral Irrigation

Leading manufacturers include Dentsply Intl., Ultradent Products, Inc. and Midian Intl..

47
Total
47
Cleared
109d
Avg days
1980
Since

FDA 510(k) Cleared Unit, Oral Irrigation Devices (Product Code EFS)

47 devices
1–24 of 47
Cleared Dec 23, 1998
AGATHA-A-H2010
K983374
Midian Intl.
Dental · 89d
Cleared Feb 10, 1997
DERMADAM
K964810
Ultradent Products, Inc.
Dental · 73d
Cleared Jun 03, 1992
INTERJET(TM) GINGIVAL CARE INSTRUMENT
K921999
Bausch & Lomb, Inc.
Dental · 35d
Cleared Sep 30, 1991
MAX-I-PROBE IRRIGATION SYSTEM
K913030
Smith & Nephew, Inc.
Dental · 83d
Cleared May 31, 1990
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES
K900178
Core-Vent Corp.
Dental · 135d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-A
K875132
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIDONTAL SCALING SOLUTION-B
K875149
Dentsply Intl.
Dental · 70d
Cleared Feb 23, 1988
PERIODONTAL SCALING SOLUTION-C
K875150
Dentsply Intl.
Dental · 70d

About Product Code EFS - Regulatory Context