Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6510](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6510) → EFS — Unit, Oral Irrigation

# EFS · Unit, Oral Irrigation

_Dental · 21 CFR 872.6510 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/EFS

## Overview

- **Product Code:** EFS
- **Device Name:** Unit, Oral Irrigation
- **Regulation:** [21 CFR 872.6510](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6510)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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](/device/K023232.md) | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | Dec 11, 2002 | SESE |
| [K001493](/device/K001493.md) | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | Oct 25, 2000 | SESE |
| [K983374](/device/K983374.md) | AGATHA-A-H2010 | Midian Intl. | Dec 23, 1998 | SESE |
| [K964810](/device/K964810.md) | DERMADAM | Ultradent Products, Inc. | Feb 10, 1997 | SESE |
| [K952234](/device/K952234.md) | BARRIER ALL FILM | Cottrell, Ltd. | Jul 31, 1995 | SESE |
| [K943182](/device/K943182.md) | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | Sep 9, 1994 | SESE |
| [K923711](/device/K923711.md) | PERIOFLEX TIP | Novadent, Ltd. | May 16, 1994 | SESE |
| [K923937](/device/K923937.md) | HYDRO FLOSS | Hydro Floss, Inc. | Feb 25, 1994 | SESE |
| [K931380](/device/K931380.md) | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | Sep 20, 1993 | SESE |
| [K923457](/device/K923457.md) | SHOWERFLOSS | Summit Marketing Group, Inc. | Sep 1, 1992 | SESE |
| [K922307](/device/K922307.md) | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | Jun 16, 1992 | SESE |
| [K921999](/device/K921999.md) | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | Jun 3, 1992 | SESE |
| [K913030](/device/K913030.md) | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | Sep 30, 1991 | SESE |
| [K910832](/device/K910832.md) | OXYFRESH OXYCARE 3000 | Oxyfresh | Apr 17, 1991 | SESE |
| [K901955](/device/K901955.md) | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | Apr 15, 1991 | SESE |
| [K905188](/device/K905188.md) | PERIO PIK | Teledyne Water Pik | Feb 15, 1991 | SESE |
| [K904850](/device/K904850.md) | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. | Jan 25, 1991 | SESE |
| [K897053](/device/K897053.md) | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell | Aug 6, 1990 | SESE |
| [K901600](/device/K901600.md) | OSSEOTITE IRRIGATION UNIT | Collagen Corp. | Jun 21, 1990 | SESE |
| [K900547](/device/K900547.md) | 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
- Dentsply Intl. — 3 clearances
- Vipont Laboratories, Inc. — 3 clearances
- Micro Motors, Inc. — 2 clearances

---

**Source:** [https://fda.innolitics.com/productcode/EFS](https://fda.innolitics.com/productcode/EFS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com