Provisa Cem
FDA 510(k) K073539 · Cavex Holland BV
510(k) numberK073539
Submission
- Device name
- Provisa Cem
- Applicant
- Cavex Holland BV
Haarlem, NL - Received
- December 17, 2007
- Decision date
- January 31, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161630 | Provicol QM PlusEMB · Traditional | Voco GmbH | 09/15/2016SE |
| K120695 | Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care KitEMB · Traditional | Dentist IN A Box Pty., Ltd. | 06/12/2012SE |
| K110759 | TempocemEMB · Abbreviated | Dmg USA, Inc. | 06/10/2011SE |
| K020158 | Non-Eugenol Temporary CementEMB · Traditional | J. Morita USA, Inc. | 03/07/2002SE |
| K941066 | Dental 911EMB · Traditional | L.A.F. Industries, Inc. | 05/24/1995SE |
| K861681 | Dentimedic Dental Emergency KitEMB · Traditional | Dentimedic | 09/23/1986SE |
| K862745 | Eugenol UspEMB · Traditional | E&D Dental Manufacturing Co. | 07/31/1986SE |
| K821581 | Den TempEMB · Traditional | Majestic Drug Co., Inc. | 06/14/1982SE |
| K801779 | Oxydental Zinc Oxide Eugenol(Zoe)CementEMB · Traditional | Oxy Dental Products, Inc. | 08/07/1980SE |
| K772315 | KwikapEMB · Traditional | Den-Mat Corp. | 01/03/1978SE |
More from Den-Mat Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K151535 | Cavex Cream AlginateELW · Traditional | 10/28/2015SE |
| K141092 | MARK3ELW · Traditional | 12/04/2014SE |
| K072245 | Emulate AdvancedELW · Traditional | 11/08/2007SE |
| K062400 | Impressix, Colorchange AlginateELW · Traditional | 11/16/2006SE |
| K061267 | Simulate, Color Change AlginateELW · Traditional | 07/10/2006SE |
| K052455 | ImpressixELW · Traditional | 11/23/2005SE |
| K051207 | Cavex OrthotraceELW · Traditional | 06/21/2005SE |
| K042806 | Quadrant UNIT-1-BONDKLE · Traditional | 11/24/2004SE |
| K032116 | Tulip ColorswitchELW · Traditional | 09/30/2003SE |
| K023466 | Tulip Alginate Impression MaterialELW · Traditional | 12/13/2002SE |
Questions and answers
When was Provisa Cem cleared by the FDA?
Provisa Cem (K073539) received a 510(k) decision of Substantially Equivalent on January 31, 2008, 45 days after the submission was received.
What is the product code of K073539?
The FDA product code is EMB – Zinc Oxide Eugenol, a Class I (low risk) device regulated under 21 CFR 872.3275.