FDA Product Code
FDA Product Code EFS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6510
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice | 2002-12-11 | Traditional | PDF ↗ |
| K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K983374 | AGATHA-A-H2010 | Midian Intl. | 1998-12-23 | Traditional | PDF ↗ |
| K964810 | DERMADAM | Ultradent Products, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K952234 | BARRIER ALL FILM | Cottrell, Ltd. | 1995-07-31 | Traditional | PDF ↗ |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | 1994-09-09 | Traditional | PDF ↗ |
| K923711 | PERIOFLEX TIP | Novadent, Ltd. | 1994-05-16 | Traditional | PDF ↗ |
| K923937 | HYDRO FLOSS | Hydro Floss, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | 1993-09-20 | Traditional | PDF ↗ |
| K923457 | SHOWERFLOSS | Summit Marketing Group, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K913030 | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K910832 | OXYFRESH OXYCARE 3000 | Oxyfresh | 1991-04-17 | Traditional | PDF ↗ |
| K901955 | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Co. | 1991-04-15 | Traditional | PDF ↗ |
| K905188 | PERIO PIK | Teledyne Water Pik | 1991-02-15 | Traditional | PDF ↗ |
| K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K897053 | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell | 1990-08-06 | Traditional | PDF ↗ |
| K901600 | OSSEOTITE IRRIGATION UNIT | Collagen Corp. | 1990-06-21 | Traditional | PDF ↗ |
| K900547 | WATER PIK(R) W/ADD'L CLAIMS | Teledyne Water Pik | 1990-06-15 | Traditional | PDF ↗ |
| K900178 | ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES | Core-Vent Corp. | 1990-05-31 | Traditional | PDF ↗ |
| K900991 | SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET | Tocad America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896890 | DYNASURG DENTAL IRRIGATION SYSTEM | Micro Motors, Inc. | 1990-02-14 | Traditional | PDF ↗ |
| K895259 | PIK POCKET(R), MODEL PP-3 | Teledyne Water Pik | 1989-11-01 | Traditional | PDF ↗ |
| K894015 | WATER PIK(R) | Teledyne Water Pik | 1989-08-28 | Traditional | PDF ↗ |
| K890600 | HYDRODENT ANTIPLAQUE SYSTEM | Hydrodent Laboratories, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K884220 | AIR WATER SYRINGE TIP SHIELD | Steri-Shield Products, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K882759 | PROFESSIONAL MODEL 7525 DELIVERY SYSTEM | Viadent | 1988-08-12 | Traditional | PDF ↗ |
| K875149 | PERIDONTAL SCALING SOLUTION-B | Dentsply Intl. | 1988-02-23 | Traditional | PDF ↗ |
| K875150 | PERIODONTAL SCALING SOLUTION-C | Dentsply Intl. | 1988-02-23 | Traditional | PDF ↗ |
| K875132 | PERIODONTAL SCALING SOLUTION-A | Dentsply Intl. | 1988-02-23 | Traditional | PDF ↗ |
| K864540 | PLAK VAK - PV-10 | Paul S. Barclay, D.D.S. , Ltd. | 1987-07-02 | Traditional | PDF ↗ |
| K863131 | PIK POCKET (IRRIGATING TIP) | Teledyne, Inc. | 1986-08-26 | Traditional | PDF ↗ |
| K852593 | SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-07-24 | Traditional | PDF ↗ |
| K844339 | BRAUN DENTAL CENTER OC-3 | The Braun Corp. | 1985-02-08 | Traditional | PDF ↗ |
| K844318 | ORAL IRRIGATION TIP | Pro Pulse, Inc. | 1984-11-23 | Traditional | PDF ↗ |
| K840721 | PERIO PIK | Teledyne, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K834545 | POCKETIP 4414 | Vipont Laboratories, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K832223 | PERIODONTAL IRRIGATOR #7620 | Vipont Laboratories, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K832222 | PRO PULSE PERIODONTAL IRRIGATOR 7618 | Vipont Laboratories, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K831321 | GUM MACHINE | The Gum Machine Co. | 1983-07-07 | Traditional | PDF ↗ |
| K823305 | DENTO SPRAY ORAL IRRIGATOR | Neo-Life Co. of America | 1982-11-24 | Traditional | PDF ↗ |
| K813638 | MULTI-UNIT, MULTI-PURPOSE DEVICE | The Scott & Fetzer Co. | 1982-05-07 | Traditional | PDF ↗ |
| K811175 | RECOH ROOT CANAL IRRIGATOR | Koei International, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K810864 | WATER PIK ORAL HYGIENE CENTER | Teledyne, Inc. | 1981-04-21 | Traditional | PDF ↗ |
| K802595 | ERGO IRRIGATION SYSTEM | Ergo Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800448 | WATER PIK TRAVELER, MODEL 79 | Teledyne, Inc. | 1980-03-05 | Traditional | PDF ↗ |
Product code EFS · Class I · Dental. Data: openFDA.