Eugenol Usp
FDA 510(k) K862745 · E&D Dental Manufacturing Co.
510(k) numberK862745
Submission
- Device name
- Eugenol Usp
- Applicant
- E&D Dental Manufacturing Co.
Hillside, NJ, US - Received
- July 21, 1986
- Decision date
- July 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K073539 | Provisa CemEMB · Traditional | Cavex Holland BV | 01/31/2008SE |
| 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 |
| 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 |
|---|---|---|
| K883698 | Zinc Oxide Eugenol Temporary CementEMA · Traditional | 11/29/1988SE |
| K873739 | Acrylic Impression Tray MaterialsEBH · Traditional | 03/07/1988SE |
| K873738 | Acrylic Base Denture MaterialsEBI · Traditional | 11/20/1987SE |
| K871639 | Dental Diamond BursDZP · Traditional | 05/18/1987SE |
| K864922 | Dental Handpieces and AttachmentEKS · Traditional | 02/19/1987SE |
Questions and answers
When was Eugenol Usp cleared by the FDA?
Eugenol Usp (K862745) received a 510(k) decision of Substantially Equivalent on July 31, 1986, 10 days after the submission was received.
What is the product code of K862745?
The FDA product code is EMB – Zinc Oxide Eugenol, a Class I (low risk) device regulated under 21 CFR 872.3275.