EFS · Class I · 21 CFR 872.6510

FDA Product Code EFS: Unit, Oral Irrigation

Leading manufacturers include Teledyne Water Pik, Teledyne, Inc. and Dentsply 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 11, 2002

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

Cleared Oct 25, 2000

DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001

Air Force, Inc.

Cleared Dec 23, 1998

Cleared Feb 10, 1997

Ultradent Products, Inc.

Cleared Jul 31, 1995

BARRIER ALL FILM

Cleared Sep 09, 1994

ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR

Oral-B Laboratories

Cleared May 16, 1994

Cleared Feb 25, 1994

Hydro Floss, Inc.

Cleared Sep 20, 1993

WATER PIK PLUS PLAQUE CONTROL SYSTEM

Teledyne Water Pik

Cleared Sep 01, 1992

Summit Marketing Group, Inc.

Cleared Jun 16, 1992

SHOWERFLOSS ORAL IRRIGATION UNIT

Showerfloss, Inc.

Cleared Jun 03, 1992

INTERJET(TM) GINGIVAL CARE INSTRUMENT

Bausch & Lomb, Inc.

Cleared Sep 30, 1991

MAX-I-PROBE IRRIGATION SYSTEM

Smith & Nephew, Inc.

Cleared Apr 17, 1991

OXYFRESH OXYCARE 3000

Cleared Apr 15, 1991

PERIOGARD(R) PERIOPEN

Colgate-Palmolive Co.

Cleared Feb 15, 1991

Teledyne Water Pik

Cleared Jan 25, 1991

DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555

Micro Motors, Inc.

Cleared Aug 06, 1990

L'LL SQUIRT GUM ORAL RINSE DEVICE

James R. Powell

Cleared Jun 21, 1990

OSSEOTITE IRRIGATION UNIT

Cleared Jun 15, 1990

WATER PIK(R) W/ADD'L CLAIMS

Teledyne Water Pik

Cleared May 31, 1990

ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES

Core-Vent Corp.

Cleared May 15, 1990

SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET

Tocad America, Inc.

Cleared Feb 14, 1990

DYNASURG DENTAL IRRIGATION SYSTEM

Micro Motors, Inc.

Cleared Nov 01, 1989

PIK POCKET(R), MODEL PP-3

Teledyne Water Pik

About Product Code EFS - Regulatory Context

Related FDA 510(k) Regulatory Insights