Unit, Oral Irrigation
Regulation 872.6510
0510(k)s in 12 months (47 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Teledyne Water Pik | 5 | 0 |
| Teledyne, Inc. | 4 | 0 |
| Dentsply Intl. | 3 | 0 |
| Vipont Laboratories, Inc. | 3 | 0 |
| Micro Motors, Inc. | 2 | 0 |
| Air Force, Inc. | 1 | 0 |
| Bausch & Lomb, Inc. | 1 | 0 |
| The Braun Corp. | 1 | 0 |
| Colgate-Palmolive Co. | 1 | 0 |
| Collagen Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2002 | K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE Smartpractice | EFS |
| Oct 25, 2000 | K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 Air Force, Inc. | EFS |
| Dec 23, 1998 | K983374 | AGATHA-A-H2010 Midian Intl. | EFS |
| Feb 10, 1997 | K964810 | DERMADAM Ultradent Products, Inc. | EFS |
| Jul 31, 1995 | K952234 | BARRIER ALL FILM Cottrell, Ltd. | EFS |
| Sep 9, 1994 | K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR Oral-B Laboratories | EFS |
| May 16, 1994 | K923711 | PERIOFLEX TIP Novadent, Ltd., IL | EFS |
| Feb 25, 1994 | K923937 | HYDRO FLOSS Hydro Floss, Inc. | EFS |
| Sep 20, 1993 | K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM Teledyne Water Pik | EFS |
| Sep 1, 1992 | K923457 | SHOWERFLOSS Summit Marketing Group, Inc. | EFS |
| Jun 16, 1992 | K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT Showerfloss, Inc. | EFS |
| Jun 3, 1992 | K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT Bausch & Lomb, Inc. | EFS |
| Sep 30, 1991 | K913030 | MAX-I-PROBE IRRIGATION SYSTEM Smith & Nephew, Inc. | EFS |
| Apr 17, 1991 | K910832 | OXYFRESH OXYCARE 3000 Oxyfresh | EFS |
| Apr 15, 1991 | K901955 | PERIOGARD(R) PERIOPEN Colgate-Palmolive Co. | EFS |
| Feb 15, 1991 | K905188 | PERIO PIK Teledyne Water Pik | EFS |
| Jan 25, 1991 | K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 Micro Motors, Inc. | EFS |
| Aug 6, 1990 | K897053 | L'LL SQUIRT GUM ORAL RINSE DEVICE James R. Powell | EFS |
| Jun 21, 1990 | K901600 | OSSEOTITE IRRIGATION UNIT Collagen Corp. | EFS |
| Jun 15, 1990 | K900547 | WATER PIK(R) W/ADD'L CLAIMS Teledyne Water Pik | EFS |
| May 31, 1990 | K900178 | ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES Core-Vent Corp. | EFS |
| May 15, 1990 | K900991 | SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET Tocad America, Inc. | EFS |
| Feb 14, 1990 | K896890 | DYNASURG DENTAL IRRIGATION SYSTEM Micro Motors, Inc. | EFS |
| Nov 1, 1989 | K895259 | PIK POCKET(R), MODEL PP-3 Teledyne Water Pik | EFS |
| Aug 28, 1989 | K894015 | WATER PIK(R) Teledyne Water Pik | EFS |
| May 5, 1989 | K890600 | HYDRODENT ANTIPLAQUE SYSTEM Hydrodent Laboratories, Inc. | EFS |
| Mar 17, 1989 | K884220 | AIR WATER SYRINGE TIP SHIELD Steri-Shield Products, Inc. | EFS |
| Aug 12, 1988 | K882759 | PROFESSIONAL MODEL 7525 DELIVERY SYSTEM Viadent | EFS |
| Feb 23, 1988 | K875150 | PERIODONTAL SCALING SOLUTION-C Dentsply Intl. | EFS |
| Feb 23, 1988 | K875149 | PERIDONTAL SCALING SOLUTION-B Dentsply Intl. | EFS |
| Feb 23, 1988 | K875132 | PERIODONTAL SCALING SOLUTION-A Dentsply Intl. | EFS |
| Jul 2, 1987 | K864540 | PLAK VAK - PV-10 Paul S. Barclay, D.D.S. , Ltd. | EFS |
| Aug 26, 1986 | K863131 | PIK POCKET (IRRIGATING TIP) Teledyne, Inc. | EFS |
| Jul 24, 1985 | K852593 | SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 Northern Electric Co. Div. of Sunbeam Corp. | EFS |
| Feb 8, 1985 | K844339 | BRAUN DENTAL CENTER OC-3 The Braun Corp. | EFS |
| Nov 23, 1984 | K844318 | ORAL IRRIGATION TIP Pro Pulse, Inc. | EFS |
| Apr 25, 1984 | K840721 | PERIO PIK Teledyne, Inc. | EFS |
| Mar 30, 1984 | K834545 | POCKETIP 4414 Vipont Laboratories, Inc. | EFS |
| Aug 31, 1983 | K832223 | PERIODONTAL IRRIGATOR #7620 Vipont Laboratories, Inc. | EFS |
| Aug 31, 1983 | K832222 | PRO PULSE PERIODONTAL IRRIGATOR 7618 Vipont Laboratories, Inc. | EFS |
| Jul 7, 1983 | K831321 | GUM MACHINE The Gum Machine Co. | EFS |
| Nov 24, 1982 | K823305 | DENTO SPRAY ORAL IRRIGATOR Neo-Life Co. of America | EFS |
| May 7, 1982 | K813638 | MULTI-UNIT, MULTI-PURPOSE DEVICE The Scott & Fetzer Co. | EFS |
| May 27, 1981 | K811175 | RECOH ROOT CANAL IRRIGATOR Koei International, Inc. | EFS |
| Apr 21, 1981 | K810864 | WATER PIK ORAL HYGIENE CENTER Teledyne, Inc. | EFS |
| Nov 12, 1980 | K802595 | ERGO IRRIGATION SYSTEM Ergo Instruments, Inc. | EFS |
| Mar 5, 1980 | K800448 | WATER PIK TRAVELER, MODEL 79 Teledyne, Inc. | EFS |
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