EFS · Class I · 21 CFR 872.6510

FDA Product Code EFS: Unit, Oral Irrigation

Leading manufacturers include Teledyne Water Pik, Teledyne, Inc. and Vipont Laboratories, Inc..

47
Total
47
Cleared
109d
Avg days
1980
Since
47 devices
25–47 of 47
Cleared Aug 28, 1989
WATER PIK(R)
K894015
Teledyne Water Pik
Dental · 83d
Cleared May 05, 1989
HYDRODENT ANTIPLAQUE SYSTEM
K890600
Hydrodent Laboratories, Inc.
Dental · 88d
Cleared Mar 17, 1989
AIR WATER SYRINGE TIP SHIELD
K884220
Steri-Shield Products, Inc.
Dental · 162d
Cleared Aug 12, 1988
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
K882759
Viadent
Dental · 38d
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
Cleared Jul 02, 1987
PLAK VAK - PV-10
K864540
Paul S. Barclay, D.D.S. , Ltd.
Dental · 225d
Cleared Aug 26, 1986
PIK POCKET (IRRIGATING TIP)
K863131
Teledyne, Inc.
Dental · 11d
Cleared Jul 24, 1985
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
K852593
Northern Electric Co. Div. of Sunbeam Corp.
Dental · 35d
Cleared Feb 08, 1985
BRAUN DENTAL CENTER OC-3
K844339
The Braun Corp.
Dental · 92d
Cleared Nov 23, 1984
ORAL IRRIGATION TIP
K844318
Pro Pulse, Inc.
Dental · 17d
Cleared Apr 25, 1984
PERIO PIK
K840721
Teledyne, Inc.
Dental · 68d
Cleared Mar 30, 1984
POCKETIP 4414
K834545
Vipont Laboratories, Inc.
Dental · 94d
Cleared Aug 31, 1983
PRO PULSE PERIODONTAL IRRIGATOR 7618
K832222
Vipont Laboratories, Inc.
Dental · 54d
Cleared Aug 31, 1983
PERIODONTAL IRRIGATOR #7620
K832223
Vipont Laboratories, Inc.
Dental · 54d
Cleared Jul 07, 1983
GUM MACHINE
K831321
The Gum Machine Co.
Dental · 76d
Cleared Nov 24, 1982
DENTO SPRAY ORAL IRRIGATOR
K823305
Neo-Life Co. of America
Dental · 19d
Cleared May 07, 1982
MULTI-UNIT, MULTI-PURPOSE DEVICE
K813638
The Scott & Fetzer Co.
Dental · 128d
Cleared May 27, 1981
RECOH ROOT CANAL IRRIGATOR
K811175
Koei International, Inc.
Dental · 29d
Cleared Apr 21, 1981
WATER PIK ORAL HYGIENE CENTER
K810864
Teledyne, Inc.
Dental · 21d
Cleared Nov 12, 1980
ERGO IRRIGATION SYSTEM
K802595
Ergo Instruments, Inc.
Dental · 22d
Cleared Mar 05, 1980
WATER PIK TRAVELER, MODEL 79
K800448
Teledyne, Inc.
Dental · 6d