Luxalloy 50 (Powder, Tablets, Predosed Capsules)
FDA 510(k) K902249 · Degussa AG
510(k) numberK902249
Submission
- Device name
- Luxalloy 50 (Powder, Tablets, Predosed Capsules)
- Applicant
- Degussa AG
West Germany, DE - Received
- May 18, 1990
- Decision date
- July 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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| K960226 | DG 88EJT · Traditional | 02/14/1996SE |
| K960104 | Biocclus 4EJT · Traditional | 02/06/1996SE |
| K955465 | DeguprintELW · Traditional | 12/28/1995SE |
| K955118 | Degubond X-Lite PlusEJT · Traditional | 12/11/1995SE |
| K955027 | Degubond X-LiteEJT · Traditional | 12/01/1995SE |
| K953344 | Degubond UltraEJT · Traditional | 08/25/1995SE |
| K951789 | Palliag NF IVEJT · Traditional | 06/14/1995SE |
Questions and answers
When was Luxalloy 50 (Powder, Tablets, Predosed Capsules) cleared by the FDA?
Luxalloy 50 (Powder, Tablets, Predosed Capsules) (K902249) received a 510(k) decision of Substantially Equivalent on July 13, 1990, 56 days after the submission was received.
What is the product code of K902249?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.