EFS · Unit, Oral Irrigation
Dental · 21 CFR 872.6510 · Class 1
Overview
| Product Code | EFS |
|---|---|
| Device Name | Unit, Oral Irrigation |
| Regulation | 21 CFR 872.6510 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | Dec 11, 2002 | SESE |
| K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | Oct 25, 2000 | SESE |
| K983374 | AGATHA-A-H2010 | Midian Intl. | Dec 23, 1998 | SESE |
| K964810 | DERMADAM | Ultradent Products, Inc. | Feb 10, 1997 | SESE |
| K952234 | BARRIER ALL FILM | Cottrell, Ltd. | Jul 31, 1995 | SESE |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | Sep 9, 1994 | SESE |
| K923711 | PERIOFLEX TIP | Novadent, Ltd. | May 16, 1994 | SESE |
| K923937 | HYDRO FLOSS | Hydro Floss, Inc. | Feb 25, 1994 | SESE |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | Sep 20, 1993 | SESE |
| K923457 | SHOWERFLOSS | Summit Marketing Group, Inc. | Sep 1, 1992 | SESE |
| K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | Jun 16, 1992 | SESE |
| K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | Jun 3, 1992 | SESE |
| K913030 | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | Sep 30, 1991 | SESE |
| K910832 | OXYFRESH OXYCARE 3000 | Oxyfresh | Apr 17, 1991 | SESE |
| K901955 | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | Apr 15, 1991 | SESE |
| K905188 | PERIO PIK | Teledyne Water Pik | Feb 15, 1991 | SESE |
| K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. | Jan 25, 1991 | SESE |
| K897053 | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell | Aug 6, 1990 | SESE |
| K901600 | OSSEOTITE IRRIGATION UNIT | Collagen Corp. | Jun 21, 1990 | SESE |
| K900547 | WATER PIK(R) W/ADD'L CLAIMS | Teledyne Water Pik | Jun 15, 1990 | SESE |
Top Applicants
- Teledyne Water Pik — 5 clearances
- Teledyne, Inc. — 4 clearances
- Vipont Laboratories, Inc. — 3 clearances
- Dentsply Intl. — 3 clearances
- Micro Motors, Inc. — 2 clearances
