Product Code: EFS FDA class 1 21 CFR 872.6510

Unit, Oral Irrigation

Dental

The Oral Irrigation Unit is a dental device that delivers a pulsating or steady stream of water or antimicrobial solution to the gingival sulcus and interproximal areas of the teeth for the removal of debris and for adjunctive plaque control in patients with periodontal disease or at elevated caries risk. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFS and the applicable regulation is 21 CFR 872.6510, under the Dental medical specialty.

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510(k)s

FEI Numbers

213

Registration Numbers

214

Unique Applicants

Years Active

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Basic Information

Product Code: EFS
Device Class: FDA class 1
Regulation Number: 872.6510
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K023232	SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE	Dec 11, 2002	Substantially Equivalent	Smartpractice
K001493	DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001	Oct 25, 2000	Substantially Equivalent	Air Force, Inc.
K983374	AGATHA-A-H2010	Dec 23, 1998	Substantially Equivalent	Midian Intl.
K964810	DERMADAM	Feb 10, 1997	Substantially Equivalent	Ultradent Products, Inc.
K952234	BARRIER ALL FILM	Jul 31, 1995	Substantially Equivalent	Cottrell, Ltd.
K943182	ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR	Sep 09, 1994	Substantially Equivalent	Oral-B Laboratories
K923711	PERIOFLEX TIP	May 16, 1994	Substantially Equivalent	Novadent, Ltd.
K923937	HYDRO FLOSS	Feb 25, 1994	Substantially Equivalent	Hydro Floss, Inc.
K931380	WATER PIK PLUS PLAQUE CONTROL SYSTEM	Sep 20, 1993	Substantially Equivalent	Teledyne Water Pik
K923457	SHOWERFLOSS	Sep 01, 1992	Substantially Equivalent	Summit Marketing Group, Inc.
K922307	SHOWERFLOSS ORAL IRRIGATION UNIT	Jun 16, 1992	Substantially Equivalent	Showerfloss, Inc.
K921999	INTERJET(TM) GINGIVAL CARE INSTRUMENT	Jun 03, 1992	Substantially Equivalent	Bausch & Lomb, Inc.
K913030	MAX-I-PROBE IRRIGATION SYSTEM	Sep 30, 1991	Substantially Equivalent	Smith & Nephew, Inc.
K910832	OXYFRESH OXYCARE 3000	Apr 17, 1991	Substantially Equivalent	Oxyfresh
K901955	PERIOGARD(R) PERIOPEN	Apr 15, 1991	Substantially Equivalent	Colgate-Palmolive Co.
K905188	PERIO PIK	Feb 15, 1991	Substantially Equivalent	Teledyne Water Pik
K904850	DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555	Jan 25, 1991	Substantially Equivalent	Micro Motors, Inc.
K897053	L'LL SQUIRT GUM ORAL RINSE DEVICE	Aug 06, 1990	Substantially Equivalent	James R. Powell
K901600	OSSEOTITE IRRIGATION UNIT	Jun 21, 1990	Substantially Equivalent	Collagen Corp.
K900547	WATER PIK(R) W/ADD'L CLAIMS	Jun 15, 1990	Substantially Equivalent	Teledyne Water Pik
K900178	ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES	May 31, 1990	Substantially Equivalent	Core-Vent Corp.
K900991	SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET	May 15, 1990	Substantially Equivalent	Tocad America, Inc.
K896890	DYNASURG DENTAL IRRIGATION SYSTEM	Feb 14, 1990	Substantially Equivalent	Micro Motors, Inc.
K895259	PIK POCKET(R), MODEL PP-3	Nov 01, 1989	Substantially Equivalent	Teledyne Water Pik
K894015	WATER PIK(R)	Aug 28, 1989	Substantially Equivalent	Teledyne Water Pik
K890600	HYDRODENT ANTIPLAQUE SYSTEM	May 05, 1989	Unknown	Hydrodent Laboratories, Inc.
K884220	AIR WATER SYRINGE TIP SHIELD	Mar 17, 1989	Substantially Equivalent	Steri-Shield Products, Inc.
K882759	PROFESSIONAL MODEL 7525 DELIVERY SYSTEM	Aug 12, 1988	Substantially Equivalent	Viadent
K875150	PERIODONTAL SCALING SOLUTION-C	Feb 23, 1988	Substantially Equivalent	Dentsply Intl.
K875149	PERIDONTAL SCALING SOLUTION-B	Feb 23, 1988	Substantially Equivalent	Dentsply Intl.
K875132	PERIODONTAL SCALING SOLUTION-A	Feb 23, 1988	Substantially Equivalent	Dentsply Intl.
K864540	PLAK VAK - PV-10	Jul 02, 1987	Substantially Equivalent	Paul S. Barclay, D.D.S. , Ltd.
K863131	PIK POCKET (IRRIGATING TIP)	Aug 26, 1986	Substantially Equivalent	Teledyne, Inc.
K852593	SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273	Jul 24, 1985	Substantially Equivalent	Northern Electric Co. Div. of Sunbeam Corp.
K844339	BRAUN DENTAL CENTER OC-3	Feb 08, 1985	Substantially Equivalent	The Braun Corp.
K844318	ORAL IRRIGATION TIP	Nov 23, 1984	Substantially Equivalent	Pro Pulse, Inc.
K840721	PERIO PIK	Apr 25, 1984	Substantially Equivalent	Teledyne, Inc.
K834545	POCKETIP 4414	Mar 30, 1984	Substantially Equivalent	Vipont Laboratories, Inc.
K832223	PERIODONTAL IRRIGATOR #7620	Aug 31, 1983	Substantially Equivalent	Vipont Laboratories, Inc.
K832222	PRO PULSE PERIODONTAL IRRIGATOR 7618	Aug 31, 1983	Substantially Equivalent	Vipont Laboratories, Inc.
K831321	GUM MACHINE	Jul 07, 1983	Substantially Equivalent	The Gum Machine Co.
K823305	DENTO SPRAY ORAL IRRIGATOR	Nov 24, 1982	Substantially Equivalent	Neo-Life Co. of America
K813638	MULTI-UNIT, MULTI-PURPOSE DEVICE	May 07, 1982	Substantially Equivalent	The Scott & Fetzer Co.
K811175	RECOH ROOT CANAL IRRIGATOR	May 27, 1981	Substantially Equivalent	Koei International, Inc.
K810864	WATER PIK ORAL HYGIENE CENTER	Apr 21, 1981	Substantially Equivalent	Teledyne, Inc.
K802595	ERGO IRRIGATION SYSTEM	Nov 12, 1980	Substantially Equivalent	Ergo Instruments, Inc.
K800448	WATER PIK TRAVELER, MODEL 79	Mar 05, 1980	Substantially Equivalent	Teledyne, Inc.