Atlas FDA

EFS

47 FDA 510(k) clearances · Product code

75 daysmedian time to decision
225 days90th percentile
47clearances measured

FDA profile

Official device name
Unit, Oral Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 872.6510
Medical specialty
Dental
Adverse events (MAUDE)
2020: 16 · 2021: 18 · 2022: 21 · 2023: 34 · 2024: 31 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (K023232)Smartpractice2002-12-11
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493)Air Force, Inc.2000-10-25
AGATHA-A-H2010 (K983374)Midian Intl.1998-12-23
DERMADAM (K964810)Ultradent Products, Inc.1997-02-10
BARRIER ALL FILM (K952234)Cottrell, Ltd.1995-07-31
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182)Oral-B Laboratories1994-09-09
PERIOFLEX TIP (K923711)Novadent, Ltd.1994-05-16
HYDRO FLOSS (K923937)Hydro Floss, Inc.1994-02-25
WATER PIK PLUS PLAQUE CONTROL SYSTEM (K931380)Teledyne Water Pik1993-09-20
SHOWERFLOSS (K923457)Summit Marketing Group, Inc.1992-09-01
SHOWERFLOSS ORAL IRRIGATION UNIT (K922307)Showerfloss, Inc.1992-06-16
INTERJET(TM) GINGIVAL CARE INSTRUMENT (K921999)Bausch & Lomb, Inc.1992-06-03
MAX-I-PROBE IRRIGATION SYSTEM (K913030)Smith & Nephew, Inc.1991-09-30
OXYFRESH OXYCARE 3000 (K910832)Oxyfresh1991-04-17
PERIOGARD(R) PERIOPEN (K901955)Colgate-Palmolive Co.1991-04-15
PERIO PIK (K905188)Teledyne Water Pik1991-02-15
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 (K904850)Micro Motors, Inc.1991-01-25
L'LL SQUIRT GUM ORAL RINSE DEVICE (K897053)James R. Powell1990-08-06
OSSEOTITE IRRIGATION UNIT (K901600)Collagen Corp.1990-06-21
WATER PIK(R) W/ADD'L CLAIMS (K900547)Teledyne Water Pik1990-06-15
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES (K900178)Core-Vent Corp.1990-05-31
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET (K900991)Tocad America, Inc.1990-05-15
DYNASURG DENTAL IRRIGATION SYSTEM (K896890)Micro Motors, Inc.1990-02-14
PIK POCKET(R), MODEL PP-3 (K895259)Teledyne Water Pik1989-11-01
WATER PIK(R) (K894015)Teledyne Water Pik1989-08-28
HYDRODENT ANTIPLAQUE SYSTEM (K890600)Hydrodent Laboratories, Inc.1989-05-05
AIR WATER SYRINGE TIP SHIELD (K884220)Steri-Shield Products, Inc.1989-03-17
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM (K882759)Viadent1988-08-12
PERIODONTAL SCALING SOLUTION-C (K875150)Dentsply Intl.1988-02-23
PERIDONTAL SCALING SOLUTION-B (K875149)Dentsply Intl.1988-02-23
PERIODONTAL SCALING SOLUTION-A (K875132)Dentsply Intl.1988-02-23
PLAK VAK - PV-10 (K864540)Paul S. Barclay, D.D.S. , Ltd.1987-07-02
PIK POCKET (IRRIGATING TIP) (K863131)Teledyne, Inc.1986-08-26
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 (K852593)Northern Electric Co. Div. of Sunbeam Corp.1985-07-24
BRAUN DENTAL CENTER OC-3 (K844339)The Braun Corp.1985-02-08
ORAL IRRIGATION TIP (K844318)Pro Pulse, Inc.1984-11-23
PERIO PIK (K840721)Teledyne, Inc.1984-04-25
POCKETIP 4414 (K834545)Vipont Laboratories, Inc.1984-03-30
PERIODONTAL IRRIGATOR #7620 (K832223)Vipont Laboratories, Inc.1983-08-31
PRO PULSE PERIODONTAL IRRIGATOR 7618 (K832222)Vipont Laboratories, Inc.1983-08-31
GUM MACHINE (K831321)The Gum Machine Co.1983-07-07
DENTO SPRAY ORAL IRRIGATOR (K823305)Neo-Life Co. of America1982-11-24
MULTI-UNIT, MULTI-PURPOSE DEVICE (K813638)The Scott & Fetzer Co.1982-05-07
RECOH ROOT CANAL IRRIGATOR (K811175)Koei International, Inc.1981-05-27
WATER PIK ORAL HYGIENE CENTER (K810864)Teledyne, Inc.1981-04-21
ERGO IRRIGATION SYSTEM (K802595)Ergo Instruments, Inc.1980-11-12
WATER PIK TRAVELER, MODEL 79 (K800448)Teledyne, Inc.1980-03-05

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Every clearance here is in the API, with alerts when new ones post.