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/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/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](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K023232.md) | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | Dec 11, 2002 | SESE | | [K001493](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K001493.md) | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | Oct 25, 2000 | SESE | | [K983374](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K983374.md) | AGATHA-A-H2010 | Midian Intl. | Dec 23, 1998 | SESE | | [K964810](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K964810.md) | DERMADAM | Ultradent Products, Inc. | Feb 10, 1997 | SESE | | [K952234](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K952234.md) | BARRIER ALL FILM | Cottrell, Ltd. | Jul 31, 1995 | SESE | | [K943182](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K943182.md) | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | Sep 9, 1994 | SESE | | [K923711](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K923711.md) | PERIOFLEX TIP | Novadent, Ltd. | May 16, 1994 | SESE | | [K923937](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K923937.md) | HYDRO FLOSS | Hydro Floss, Inc. | Feb 25, 1994 | SESE | | [K931380](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K931380.md) | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | Sep 20, 1993 | SESE | | [K923457](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K923457.md) | SHOWERFLOSS | Summit Marketing Group, Inc. | Sep 1, 1992 | SESE | | [K922307](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K922307.md) | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | Jun 16, 1992 | SESE | | [K921999](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K921999.md) | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | Jun 3, 1992 | SESE | | [K913030](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K913030.md) | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | Sep 30, 1991 | SESE | | [K910832](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K910832.md) | OXYFRESH OXYCARE 3000 | Oxyfresh | Apr 17, 1991 | SESE | | [K901955](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K901955.md) | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | Apr 15, 1991 | SESE | | [K905188](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K905188.md) | PERIO PIK | Teledyne Water Pik | Feb 15, 1991 | SESE | | [K904850](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K904850.md) | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. | Jan 25, 1991 | SESE | | [K897053](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K897053.md) | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell | Aug 6, 1990 | SESE | | [K901600](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K901600.md) | OSSEOTITE IRRIGATION UNIT | Collagen Corp. | Jun 21, 1990 | SESE | | [K900547](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/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/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/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. 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