AURORA 53

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964949 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Gpw-Sf

  Class II

  FDA 510(k) K011659 Active Cleared 27 Aug 2001

• Solder Gpw

  Class II

  FDA 510(k) K964713 Active Cleared 16 Dec 1996

• Solder 585

  Class II

  FDA 510(k) K964707 Active Cleared 16 Dec 1996

• Pacific 52 (Cb-39)

  Class II

  FDA 510(k) K964464 Active Cleared 26 Nov 1996

• Palladia 85 (Pm-13)

  Class II

  FDA 510(k) K964838 Active Cleared 20 Dec 1996

• Ozark 40

  Class II

  FDA 510(k) K964477 Active Cleared 2 Dec 1996

See all devices from Gateway Alloys, Inc. →

• What is the AURORA 53 device used for?

  The AURORA 53 is a gold-based noble metal alloy specifically designed for dental applications. It is manufactured by Gateway Alloys, Inc. and is classified as a Class II medical device.

• In what forms is the AURORA 53 supplied?

  The device is supplied in various sizes to accommodate different dental applications. The specific size options are not detailed in the available information.

• What is the regulatory status of the AURORA 53?

  The AURORA 53 received FDA 510(k) clearance on January 13, 1997, with product code EJT, and is regulated under number 872.3060. It is classified as a Class II medical device.

• Is the AURORA 53 a single-use device?

  The device data does not specify whether the AURORA 53 is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.

• How should the AURORA 53 be stored?

  The device data does not provide specific storage instructions for the AURORA 53. Proper storage requirements would typically be outlined in the product's instructions for use or provided by the manufacturer.