Water Pik(R) W/Add'L Claims
FDA 510(k) K900547 · Teledyne Water Pik
510(k) numberK900547
Submission
- Device name
- Water Pik(R) W/Add'L Claims
- Applicant
- Teledyne Water Pik
Fort Collins, CO, US - Received
- February 5, 1990
- Decision date
- June 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023232 | Splatrfree Swangle 360 Disposable Prophylaxis AngleEFS · Traditional | Smartpractice | 12/11/2002SE |
| K001493 | Dental Air Force Home Dental Cleaning System, Model No. 0020001EFS · Traditional | Air Force, Inc. | 10/25/2000SE |
| K983374 | AGATHA-A-H2010EFS · Traditional | Midian Intl. | 12/23/1998SE |
| K964810 | DermadamEFS · Traditional | Ultradent Products, Inc. | 02/10/1997SE |
| K952234 | Barrier All FilmEFS · Traditional | Cottrell, Ltd. | 07/31/1995SE |
| K943182 | Oral-B Perioflex Subgingival IrrigatorEFS · Traditional | Oral-B Laboratories | 09/09/1994SE |
| K923711 | Perioflex TipEFS · Traditional | Novadent, Ltd. | 05/16/1994SE |
| K923937 | Hydro FlossEFS · Traditional | Hydro Floss, Inc. | 02/25/1994SE |
| K931380 | Water Pik Plus Plaque Control SystemEFS · Traditional | Teledyne Water Pik | 09/20/1993SE |
| K923457 | ShowerflossEFS · Traditional | Summit Marketing Group, Inc. | 09/01/1992SE |
More from Summit Marketing Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970594 | Kalginate Impression MaterialELW · Traditional | 03/31/1997SE |
| K952422 | Elastic Impression CreamELW · Traditional | 08/29/1995SE |
| K944162 | Denar Accuceph Cephalometer Imaging SystemEAG · Traditional | 11/29/1994SE |
| K940288 | Water Pik Sensonic Plaque Removal InstrumentJEQ · Traditional | 05/26/1994SE |
| K931380 | Water Pik Plus Plaque Control SystemEFS · Traditional | 09/20/1993SE |
| K905188 | Perio PikEFS · Traditional | 02/15/1991SE |
| K895259 | Pik Pocket(R), Model PP-3EFS · Traditional | 11/01/1989SE |
| K894015 | Water Pik(R)EFS · Traditional | 08/28/1989SE |
Questions and answers
When was Water Pik(R) W/Add'L Claims cleared by the FDA?
Water Pik(R) W/Add'L Claims (K900547) received a 510(k) decision of Substantially Equivalent on June 15, 1990, 130 days after the submission was received.
What is the product code of K900547?
The FDA product code is EFS – Unit, Oral Irrigation, a Class I (low risk) device regulated under 21 CFR 872.6510.