SELECT 40

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

510(k) Number

K895069 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Low Fusing White Gold

  Class II

  FDA 510(k) K895056 Active Cleared 19 Dec 1989

• Silver-Free Ceramic Solder (Sfcs)

  Class II

  FDA 510(k) K902372 Active Cleared 28 Jun 1990

• Silhouette Porcelain

  Class II

  FDA 510(k) K895888 Active Cleared 10 Apr 1990

• Monogram III

  Class II

  FDA 510(k) K895065 Active Cleared 18 Dec 1989

• .585 Fine Gold Solder

  Class II

  FDA 510(k) K895052 Active Cleared 18 Dec 1989

• Select 50

  Class II

  FDA 510(k) K895068 Active Cleared 18 Dec 1989

See all devices from Leach and Dillon Co., Inc. →

• What is the SELECT 40 dental device used for?

  SELECT 40 is a dental device classified as an Alloy, Gold-Based Noble Metal. It is a Class II device that has been determined to be substantially equivalent to predicate devices, commonly used in dental restorations and prosthetics.

• How is the SELECT 40 device supplied?

  The SELECT 40 device is supplied in various sizes as indicated by the multiple registration numbers associated with this product code EJT. The specific sizes and configurations would be detailed in the product documentation provided by the manufacturer.

• What is the regulatory status of the SELECT 40 device?

  The SELECT 40 device has been cleared through the FDA 510(k) process on December 19, 1989 with K number K895069. It is classified as a Class II device and has been determined to be substantially equivalent to predicate devices.

• Who manufactures the SELECT 40 dental device?

  The SELECT 40 dental device is manufactured by Leach and Dillon Co., Inc., located at 171 Forbes Blvd., Mansfield, MA 02048. The company has been producing this device since it received FDA clearance in 1989.