CERADELTA

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

510(k) Number

K911671 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• V-Delta, Sf

  Class II

  FDA 510(k) K911537 Active Cleared 29 Apr 1991

• Solaro 4

  Class II

  FDA 510(k) K911544 Active Cleared 29 Apr 1991

• V-Deltabond

  Class II

  FDA 510(k) K911536 Active Cleared 29 Apr 1991

• V92

  Class II

  FDA 510(k) K911533 Active Cleared 29 Apr 1991

• Standard S1

  Class II

  FDA 510(k) K912303 Active Cleared 26 Jun 1991

• VS1B

  Class II

  FDA 510(k) K912299 Active Cleared 26 Jun 1991

See all devices from Metalor Dental USA Corp. →

• What clinical applications is CERADELTA intended for?

  CERADELTA is a gold‑based other noble metal alloy designed for dental applications, providing the physical and chemical properties needed for restorations, prosthetics, and other dental procedures where a noble metal is required.

• How is CERADELTA packaged and supplied to clinicians?

  The alloy is supplied by Metalor Dental USA Corp. as a Class II device under FDA 510(k) clearance. It is provided in a form suitable for dental laboratory use, though the exact packaging format (e.g., ingots or pre‑cast blanks) is not detailed in the data.

• Is CERADELTA a sterile or single‑use product?

  The device description does not specify sterility or single‑use status. As a dental alloy intended for laboratory processing, it is typically handled in a controlled environment rather than being supplied sterile or as a disposable item.

• What regulatory clearance does CERADELTA have?

  CERADELTA received FDA 510(k) clearance (K911671) on July 10 1991, classified as a Class II device with special controls and assigned product code EJS, indicating it is substantially equivalent to a previously cleared dental alloy.