Butler Gum Prophy Paste with Novamin
FDA 510(k) K024343 · Usbiomaterials Corp.
510(k) numberK024343
Submission
- Device name
- Butler Gum Prophy Paste with Novamin
- Applicant
- Usbiomaterials Corp.
Alachua, FL, US - Received
- December 27, 2002
- Decision date
- July 11, 2003
- 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 |
|---|---|---|
| K000149 | Novabone-Bioglass Bone Graft ParticulateLYC · Special | 02/07/2000SE |
| K992416 | Perioglas- Bioglass Bone Graft ParticulateLYC · Traditional | 10/15/1999SE |
| K962494 | Perioglas - Bioglass Bone Graft ParticulateLYC · Traditional | 09/20/1996SE |
| K930115 | PerioglassLYC · Traditional | 11/04/1993SE |
Questions and answers
When was Butler Gum Prophy Paste with Novamin cleared by the FDA?
Butler Gum Prophy Paste with Novamin (K024343) received a 510(k) decision of Substantially Equivalent on July 11, 2003, 196 days after the submission was received.
What is the product code of K024343?
The FDA product code is EJR – Agent, Polishing, Abrasive, Oral Cavity, a Class I (low risk) device regulated under 21 CFR 872.6030.