Remanium:gm 700, Gm 380, Gm 800, Gfh

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

510(k) Number

K952867 ↗

FDA Product Code

EJH

Device Class

Class II

Regulation

21 CFR Part 872.3710

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dentaurum Dentaform Bands, Dentaurum Standard

  Class I

  FDA 510(k) K935152 Active Cleared 31 Jan 1994

• Dentaurum Steel Ligature Wires

  Class I

  FDA 510(k) K935140 Active Cleared 4 Feb 1994

• Remanium: 200, Cs, 380, and Cd

  Class II

  FDA 510(k) K952865 Active Cleared 26 Jul 1995

• Dentaurum Band Seater and Band Seating Instruments

  Class I

  FDA 510(k) K935156 Active Cleared 3 Feb 1994

• Dentaurum Metal Brackets

  Class I

  FDA 510(k) K935122 Active Cleared 31 Jan 1994

• Remanium: Cs & G-Soft

  Class II

  FDA 510(k) K952870 Active Cleared 27 Jul 1995

See all devices from Dentauraum, Inc. →

• What is REMANIUM:GM 700, GM 380, GM 800, GFH used for?

  REMANIUM:GM 700, GM 380, GM 800, GFH is a dental alloy used in casting applications for dental prosthetics, as defined by FDA product code EJH for alloy, metal, base materials in dental devices.

• How is REMANIUM:GM 700, GM 380, GM 800, GFH supplied and is it reusable?

  The device is supplied as a dental alloy for use in dental prosthetics and is intended for single-use in casting applications; reuse is not indicated in the provided data, and no reprocessing instructions are specified.

• What regulatory pathway was used for REMANIUM:GM 700, GM 380, GM 800, GFH and when was it cleared?

  REMANIUM:GM 700, GM 380, GM 800, GFH was cleared through the FDA 510(k) process under K952867 on July 27, 1995, and is classified as a Class II device based on substantial equivalence to a predicate device.