Securalloy
FDA 510(k) K982671 · Specialites Septodont
510(k) numberK982671
Submission
- Device name
- Securalloy
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- July 31, 1998
- Decision date
- October 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053114 | SilverfilEJJ · Traditional | Dunia Perwira Manufacturing Sdn. Bhd. | 11/15/2005SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | Septodont | 05/02/2005SE |
| K033434 | BestaloyEJJ · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032152 | Benco AdmixEJJ · Traditional | Southern Dental Industries, Inc. | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | Southern Dental Industries, Inc. | 07/29/2003SE |
| K020452 | High Silver ConventionalEJJ · Traditional | Ab Ardent | 05/07/2002SE |
| K011801 | Futura Topcap Non GAMMA-2EJJ · Traditional | Ab Ardent | 08/16/2001SE |
| K002811 | Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002810 | Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002808 | Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
More from Nordiska Dental AB
| 510(k) | Device | Decision |
|---|---|---|
| K012427 | Pharmaethyl Local Pulp and Vitality Testing AgentEAT · Traditional | 10/09/2001SE |
| K010415 | IsodanKLE · Traditional | 07/23/2001SE |
| K982773 | Quickset Liquid and PowderEMA · Traditional | 11/03/1998SE |
| K980633 | Endosolv EKIF · Traditional | 05/01/1998SE |
| K920692 | Septocalcine UltraEJK · Traditional | 04/21/1992SE |
| K915467 | Cimpat S Dental CementEMA · Traditional | 02/03/1992SE |
| K915466 | Septopack Temporary FillingEBG · Traditional | 02/03/1992SE |
| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | 11/07/1991SE |
| K913572 | Autopack Non-Eugenol Periodontal DressingEMA · Traditional | 10/09/1991SE |
| K913574 | Septocal Cavity LinerEJK · Traditional | 09/30/1991SE |
Questions and answers
When was Securalloy cleared by the FDA?
Securalloy (K982671) received a 510(k) decision of Substantially Equivalent on October 19, 1998, 80 days after the submission was received.
What is the product code of K982671?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.