Orbic Spherical Alloy

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

510(k) Number

K812827 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Orbic Spherical Alloy used for in dental restorations?

  The Orbic Spherical Alloy is designed specifically for dental amalgam mixtures where precise spherical alloy formulations are required. It is intended for use in restorative procedures, providing a consistent composition to improve the quality and longevity of dental fillings. This alloy is particularly suited for applications where traditional amalgam blends may not achieve the desired mechanical properties or marginal adaptation.

• Is the Orbic Spherical Alloy sterile when supplied, and how should it be handled?

  The Orbic Spherical Alloy is not sterile at the time of supply. It is intended for single-use in dental offices and must be handled according to standard dental protocols. Proper mixing and preparation are required before use, following established amalgamation techniques to ensure optimal performance and patient safety. Always adhere to local infection control guidelines when preparing and using the alloy.

• Can the Orbic Spherical Alloy be reused, or is it designed for single-use only?

  The Orbic Spherical Alloy is explicitly designed for single-use only. Dental amalgams are formulated to achieve specific physical properties when mixed fresh, and reusing alloy particles can compromise the integrity of the restoration. Reuse may lead to inconsistent results, reduced strength, or increased risk of contamination. Always use a fresh portion for each patient procedure to maintain clinical efficacy and compliance with dental practice standards.

• What regulatory approval does the Orbic Spherical Alloy hold, and how is it classified?

  The Orbic Spherical Alloy holds FDA 510(k) clearance (K812827) and is classified under Class II with special controls. This classification reflects its role as a dental material requiring performance standards to ensure safety and effectiveness in restorative procedures. The clearance indicates that the device meets regulatory requirements for dental amalgam alloys, though it does not imply sterility or suitability for all clinical scenarios without proper handling.

• Are there different sizes or models of the Orbic Spherical Alloy, and how should it be stored?

  The provided data does not specify distinct sizes or models for the Orbic Spherical Alloy, but it is supplied as a standard spherical alloy formulation for dental amalgam mixtures. Storage should follow general dental material guidelines: keep in a dry, sealed container away from moisture, extreme temperatures, or direct sunlight. Avoid contamination with oils, chemicals, or other substances that could compromise the alloy’s integrity before use. Always check the packaging for any manufacturer-specific storage instructions.