Alloy, Amalgam, Disp. Capsule

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

510(k) Number

K781242 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Precise(R) Beta Quartz Glass-Ceramic Insert

  Class II

  FDA 510(k) K912256 Active Cleared 24 Jul 1991

• Lee Endofill, Root Canal Filling Resin

  Class II

  FDA 510(k) K810923 Active Cleared 21 Apr 1981

• Ultraviolet Rad-Emitting Lamp

  Class II

  FDA 510(k) K771077 Active Cleared 24 Jun 1977

• Restobond 3/Dentin-Enamel Bonding Agent

  Class II

  FDA 510(k) K894315 Active Cleared 31 Oct 1989

• Cleanse N Bond I

  Class II

  FDA 510(k) K844133 Active Cleared 4 Jan 1985

• Restodent Vl

  Class II

  FDA 510(k) K843363 Active Cleared 25 Oct 1984

See all devices from Lee Pharmaceuticals →

• What is the primary use of these dental amalgam capsules in a clinical setting?

  These dental amalgam capsules are designed to hold a silver alloy that mixes with mercury to create dental amalgam, a durable filling material used in restorative dentistry to treat cavities. They are specifically intended for use in dental offices to prepare amalgam fillings for patients.

• Are these capsules meant for single-use or can they be reused?

  The capsules are explicitly labeled as single-use items, meaning each capsule is intended for one-time use only. This ensures sterility and safety for the patient during dental procedures.

• What storage conditions should be followed for these dental amalgam capsules?

  While specific storage instructions aren’t detailed in the provided data, dental amalgam capsules are generally recommended to be stored in a cool, dry place, away from direct sunlight and extreme temperatures. Since they are non-sterile, they should also be kept in a sealed, clean environment to prevent contamination.

• How were these capsules approved by the FDA, and what does that mean for their use?

  These capsules were cleared through the FDA’s 510(k) process, specifically under the traditional clearance route, and are classified as Class II devices under product code EJJ. This means they were determined to be substantially equivalent to a legally marketed predicate device and meet FDA’s special controls for dental devices, ensuring they meet established safety and performance standards for dental amalgam capsules.