Porta Geo Ti Model #2004

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

510(k) Number

K012834 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Blue Glanz +

  Class IIa

  CE/MDR

• WHITE NEM EASY Disc 13, 5 mm

  Class IIa

  CE/MDR

• Blue Nem +

  Class IIa

  CE/MDR

• CoCrMo6 Fraesrohling 98, 5x25mm

  Class IIa

  CE/MDR

• Denseo NEM Blank

  Class IIa

  CE/MDR

• AGC® Glanzzusatz Color

  Class IIa

  CE/MDR

See all devices from Wieland Edelmetalle GmbH & Co. →

• What is the Porta Geo Ti Model #2004 used for in dental laboratories?

  The Porta Geo Ti Model #2004 is a gold-platinum ceramic alloy (with 95.4% noble metal content) specifically designed for dental technicians to fabricate dental restorations. These include inlays, onlays, partial crowns, crowns, and bridges. Its extra-hard composition and copper-free formulation make it ideal for casting or machining into desired shapes before potential veneering with dental ceramics. This alloy supports precise fabrication techniques, particularly in telescopic and milling applications.

• Is the Porta Geo Ti Model #2004 supplied as a single-use or reusable material?

  The Porta Geo Ti Model #2004 is supplied as a reusable dental material. It is intended for repeated use in dental laboratories, where it can be cast or machined into various restoration shapes. Unlike single-use materials, this alloy is designed to be processed multiple times, provided it is handled and stored properly to maintain its integrity and performance.

• What are the key specifications that distinguish this alloy from other dental materials?

  The Porta Geo Ti Model #2004 is distinguished by its gold-platinum ceramic alloy composition, containing 95.4% noble metals, and its copper-free formulation. This alloy is classified as extra-hard, making it suitable for demanding dental applications like inlays, crowns, and bridges. Its copper-free nature enhances compatibility with telescopic and milling techniques, ensuring precise fabrication. Additionally, it is regulated under FDA 510(k) clearance (K012834) and falls under product code EJT as a Class II medical device.

• How should the Porta Geo Ti Model #2004 be stored to ensure optimal performance?

  While the provided specifications do not explicitly detail storage conditions, reusable dental alloys like the Porta Geo Ti Model #2004 generally require protection from moisture, contamination, and extreme temperatures. It should be stored in a clean, dry environment, preferably in its original packaging or a sealed container to prevent exposure to airborne particles or humidity. Proper storage ensures the alloy retains its mechanical properties and compatibility for casting or machining.

• Does the Porta Geo Ti Model #2004 require sterilization before use, and if so, what method is recommended?

  The specifications for the Porta Geo Ti Model #2004 do not mention sterility or provide guidance on sterilization methods. Since it is a reusable dental alloy intended for laboratory use, it is typically handled in a controlled environment where contamination is minimized. If sterilization is required, it would depend on local regulatory or facility protocols. However, dental alloys are generally not sterilized in the same way as disposable instruments, as their mechanical properties could be compromised by sterilization processes like autoclaving or chemical sterilization.