Ana 70 Non Gamma 2 Dispersed Phase Dental Alloy
FDA 510(k) K002811 · Nordiska Dental AB
510(k) numberK002811
Submission
- Device name
- Ana 70 Non Gamma 2 Dispersed Phase Dental Alloy
- Applicant
- Nordiska Dental AB
Lynwood, WA, US - Received
- September 8, 2000
- Decision date
- October 31, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
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Questions and answers
When was Ana 70 Non Gamma 2 Dispersed Phase Dental Alloy cleared by the FDA?
Ana 70 Non Gamma 2 Dispersed Phase Dental Alloy (K002811) received a 510(k) decision of Substantially Equivalent on October 31, 2000, 53 days after the submission was received.
What is the product code of K002811?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.