Product code EFS
- Device name
- Unit, Oral Irrigation
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6510
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | 2002-12-11 |
| K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | 2000-10-25 |
| K983374 | AGATHA-A-H2010 | Midian Intl. | 1998-12-23 |
| K964810 | DERMADAM | Ultradent Products, Inc. | 1997-02-10 |
| K952234 | BARRIER ALL FILM | Cottrell, Ltd. | 1995-07-31 |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | 1994-09-09 |
| K923711 | PERIOFLEX TIP | Novadent, Ltd. | 1994-05-16 |
| K923937 | HYDRO FLOSS | Hydro Floss, Inc. | 1994-02-25 |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | 1993-09-20 |
| K923457 | SHOWERFLOSS | Summit Marketing Group, Inc. | 1992-09-01 |
| K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | 1992-06-16 |
| K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | 1992-06-03 |
| K913030 | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | 1991-09-30 |
| K910832 | OXYFRESH OXYCARE 3000 | Oxyfresh | 1991-04-17 |
| K901955 | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | 1991-04-15 |
| K905188 | PERIO PIK | Teledyne Water Pik | 1991-02-15 |
| K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. | 1991-01-25 |
| K897053 | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell | 1990-08-06 |
| K901600 | OSSEOTITE IRRIGATION UNIT | Collagen Corp. | 1990-06-21 |
| K900547 | WATER PIK(R) W/ADD'L CLAIMS | Teledyne Water Pik | 1990-06-15 |
| K900178 | ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES | Core-Vent Corp. | 1990-05-31 |
| K900991 | SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET | Tocad America, Inc. | 1990-05-15 |
| K896890 | DYNASURG DENTAL IRRIGATION SYSTEM | Micro Motors, Inc. | 1990-02-14 |
| K895259 | PIK POCKET(R), MODEL PP-3 | Teledyne Water Pik | 1989-11-01 |
| K894015 | WATER PIK(R) | Teledyne Water Pik | 1989-08-28 |
| K890600 | HYDRODENT ANTIPLAQUE SYSTEM | Hydrodent Laboratories, Inc. | 1989-05-05 |
| K884220 | AIR WATER SYRINGE TIP SHIELD | Steri-Shield Products, Inc. | 1989-03-17 |
| K882759 | PROFESSIONAL MODEL 7525 DELIVERY SYSTEM | Viadent | 1988-08-12 |
| K875150 | PERIODONTAL SCALING SOLUTION-C | Dentsply Intl. | 1988-02-23 |
| K875132 | PERIODONTAL SCALING SOLUTION-A | Dentsply Intl. | 1988-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060640673700 | Ordo | ORDOCLUB LTD | 2026-05-29 |
| 00073950346788 | Waterpik Cordless Pulse 3100 Water Flosser | WATER PIK, INC. | 2026-05-26 |
| 08809260475694 | Oral irrigation unit | Saeshin Precision Co., Ltd. | 2026-05-21 |
| 08809260475687 | Oral irrigation unit | Saeshin Precision Co., Ltd. | 2026-05-21 |
| 08052141312025 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08052141312780 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08052141312865 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08052141312940 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08052141313602 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08052141311806 | Irrigation Line | OMNIA SRL | 2026-03-27 |
| 08056646509973 | Irrigation Set | OMNIA SRL | 2024-11-11 |
| 08056646509997 | Irrigation Set | OMNIA SRL | 2024-11-11 |
| 08057949140573 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-10-01 |
| 08057949140511 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-10-01 |
| 08057949140672 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-09-30 |
| 08057949140900 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-08-29 |
| 08057949140719 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-08-29 |
| 08057949140634 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2024-08-29 |
| 08057949140450 | Dental irrigation kit | ANCHIPLAST SRL | 2024-08-29 |
| 08052141311417 | Irrigation line, Kavo | OMNIA SRL | 2023-08-08 |
| 08052141311431 | Irrigation line, Kavo | OMNIA SRL | 2023-08-08 |
| 08057949140863 | MEDICAL IRRIGATION KIT | ANCHIPLAST SRL | 2022-11-11 |
| 08057949141471 | DENTAL IRRIGATION KIT | ANCHIPLAST SRL | 2022-11-11 |
| 08056646508525 | Irrigation line, W&H | OMNIA SRL | 2022-02-18 |
| 08056646508501 | Irrigation line, W&H | OMNIA SRL | 2022-02-18 |
| 08056646503872 | Infusion Sets, Bien Air | OMNIA SRL | 2021-08-09 |
| 08056646503896 | Infusion Sets, Bien Air | OMNIA SRL | 2021-08-09 |
| 08056646504947 | Irrigation line, Bien Air | OMNIA SRL | 2021-08-09 |
| 08056646504923 | Manual irrigation line, Nobel | OMNIA SRL | 2021-07-21 |
| 08056646504909 | Irrigation line, Nobel | OMNIA SRL | 2021-07-21 |