Perioflex Tip
FDA 510(k) K923711 · Novadent, Ltd.
510(k) numberK923711
Submission
- Device name
- Perioflex Tip
- Applicant
- Novadent, Ltd.
Jerusalem, IL - Received
- July 27, 1992
- Decision date
- May 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K922307 | Showerfloss Oral Irrigation UnitEFS · Traditional | Showerfloss, Inc. | 06/16/1992SE |
Questions and answers
When was Perioflex Tip cleared by the FDA?
Perioflex Tip (K923711) received a 510(k) decision of Substantially Equivalent on May 16, 1994, 658 days after the submission was received.
What is the product code of K923711?
The FDA product code is EFS – Unit, Oral Irrigation, a Class I (low risk) device regulated under 21 CFR 872.6510.