Bio PontoStar

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K983077 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Wirobond C

  Class II

  FDA 510(k) K032136 Active Cleared 4 Sep 2003

• Aurolloyd Kf

  Class II

  FDA 510(k) K983080 Active Cleared 28 Oct 1998

• Begopal

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  FDA 510(k) K983078 Active Cleared 23 Oct 1998

• Platinlloyd 100

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  FDA 510(k) K983079 Active Cleared 23 Oct 1998

• Begocer G

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  FDA 510(k) K983082 Active Cleared 28 Oct 1998

• Gold Dental Casting Alloys

  Class II

  FDA 510(k) K033279 Active Cleared 15 Jan 2004

• What is the Bio PontoStar alloy used for in dental restorations?

  The Bio PontoStar is a high-gold-content, noble metal alloy specifically designed for metal-ceramic dental restorations. It is intended for use in fixed dental prosthetics such as crowns, bridges, and abutments, where its biocompatible and corrosion-resistant properties help ensure long-term stability and patient comfort.

• Is the Bio PontoStar alloy single-use or reusable?

  The Bio PontoStar alloy is a reusable dental material. It is meant to be used repeatedly in dental laboratories and clinics for blending with plastics and conventional ceramics, provided it is handled according to standard dental material safety protocols.

• Does the Bio PontoStar alloy require special handling or storage?

  While the device data does not specify exact storage conditions, reusable dental alloys like Bio PontoStar should be stored in a clean, dry environment to prevent contamination. Always follow manufacturer guidelines and dental material safety protocols to maintain sterility and integrity before use.

• What makes the Bio PontoStar alloy distinct from other dental alloys?

  The Bio PontoStar alloy stands out due to its high-gold-content composition while being palladium-free and copper-free. This formulation enhances biocompatibility and corrosion resistance, making it suitable for metal-ceramic applications where these properties are critical for patient outcomes.

• What regulatory approval does the Bio PontoStar alloy have?

  The Bio PontoStar alloy is regulated under the FDA 510(k) clearance process and holds clearance number K983077. It is classified as a Class II device under product code EJT and is authorized for use in the United States under regulation number 872.3060.