High Silver Conventional
FDA 510(k) K020452 · Ab Ardent
510(k) numberK020452
Submission
- Device name
- High Silver Conventional
- Applicant
- Ab Ardent
Tonawanda, NY, US - Received
- February 11, 2002
- Decision date
- May 7, 2002
- 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 |
| 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 |
| K991481 | ParagonEJJ · Traditional | Lancer Orthodontics, Inc. | 08/11/1999SE |
More from Lancer Orthodontics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131753 | MeridianEBF · Abbreviated | 11/14/2013SE |
| K040465 | Latit FlowEBF · Traditional | 07/20/2004SE |
| K022971 | Microhybrid 11EBF · Traditional | 11/25/2002SE |
| K022975 | Etching 15EBF · Traditional | 11/22/2002SE |
| K022974 | Microhybrid 12EBF · Traditional | 11/22/2002SE |
| K022973 | Adhesive 14KLE · Traditional | 11/22/2002SE |
| K022972 | Microfill 13EBF · Traditional | 11/22/2002SE |
| K011801 | Futura Topcap Non GAMMA-2EJJ · Traditional | 08/16/2001SE |
| K991974 | Futura Glass Ionomer Silver ReinforcedEMA · Traditional | 09/17/1999SE |
| K982460 | Vivacap HREJJ · Traditional | 08/24/1998SE |
Questions and answers
When was High Silver Conventional cleared by the FDA?
High Silver Conventional (K020452) received a 510(k) decision of Substantially Equivalent on May 7, 2002, 85 days after the submission was received.
What is the product code of K020452?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.