Zircon-F Prophylaxis Paste
FDA 510(k) K040988 · Pascal Co., Inc.
510(k) numberK040988
Submission
- Device name
- Zircon-F Prophylaxis Paste
- Applicant
- Pascal Co., Inc.
Bellevue, WA, US - Received
- April 15, 2004
- Decision date
- July 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powderEJR · Traditional | E.M.S Electro Medical Systems S.A | 09/11/2017SE |
| K131760 | Whip Mix Preppies PlusEJR · Traditional | Whip-Mix Corp. | 03/26/2014SE |
| K121698 | Nupro Sensodyne Prophylaxis Paste with NovaminEJR · Traditional | Dentsply International, Inc. | 08/06/2012SE |
| K103114 | Osspray Sylc CREJR · Traditional | Osspray, Ltd. | 03/14/2011SE |
| K102053 | Butler Calci-Flor Prophylaxis PasteEJR · Traditional | Sunstar Americas, Inc. | 02/03/2011SE |
| K101104 | Remin ProEJR · Traditional | Voco GmbH | 10/21/2010SE |
| K100539 | Preventech Prophylaxis Paste with FluorideEJR · Traditional | Preventive Technologies, Inc. | 06/17/2010SE |
| K070854 | GC Mi Paste PlusEJR · Special | GC America, Inc. | 04/12/2007SE |
| K062502 | Osspray Cleaning CompoundEJR · Traditional | Ospray, Ltd. | 12/15/2006SE |
| K062166 | Enamel ProEJR · Traditional | Premier Dental Products Co. | 11/21/2006SE |
More from Premier Dental Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K102526 | BLO2X Oxygen BlockerEBF · Traditional | 10/22/2010SE |
| K090597 | Fluorilaq Sodium Fluoride Cavity VarnishLBH · Special | 03/16/2009SE |
| K040661 | Radent Prophy PasteEJR · Traditional | 06/09/2004SE |
| K012889 | Banicide Liquid Chemical Sterilant/High-Level DisinfectantMED · Traditional | 05/27/2003SE |
| K030488 | FluorilaqLBH · Traditional | 05/02/2003SE |
| K912632 | OccludeEFH · Traditional | 01/17/1992SE |
| K911259 | HydentEFH · Traditional | 06/06/1991SE |
Questions and answers
When was Zircon-F Prophylaxis Paste cleared by the FDA?
Zircon-F Prophylaxis Paste (K040988) received a 510(k) decision of Substantially Equivalent on July 7, 2004, 83 days after the submission was received.
What is the product code of K040988?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.