PORTA REFLEX

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

510(k) Number

K040672 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K020192 Active Cleared 15 Mar 2002

• Agc Special Alloy

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  FDA 510(k) K022470 Active Cleared 18 Sep 2002

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See all devices from Wieland Dental + Technik GmbH & Co. KG →

• What is PORTA REFLEX used for in dental applications?

  PORTA REFLEX is a gold-based noble metal alloy used to manufacture dental restorations such as inlays, onlays, partial and full crowns, short and long span bridges, removable partial dentures, and for telescopic and milling work. It can be veneered with dental ceramics or composites to match natural tooth appearance.

• How is PORTA REFLEX supplied and by whom?

  PORTA REFLEX is supplied by Wieland Dental + Technik GmbH & Co. KG, located in Pforzheim, Germany. It is provided as a dental alloy material for use by dental technicians in laboratory fabrication of patient-specific restorations.

• Is PORTA REFLEX a single-use or reusable device?

  PORTA REFLEX is not a single-use device; it is a material used by dental technicians to fabricate restorations. The alloy itself is not consumed during use but is shaped into dental appliances that are then placed in the patient’s mouth, where the final restoration remains long-term.

• What regulatory clearance does PORTA REFLEX have?

  PORTA REFLEX received FDA 510(k) clearance under number K040672 on May 27, 2004. It is classified as a Class II medical device under product code EJT and regulation number 872.3060, which governs gold-based noble metal alloys for dental use.

• What are the storage and handling requirements for PORTA REFLEX?

  The device data does not specify storage or handling requirements for PORTA REFLEX. As a noble metal alloy, it is typically stable under normal laboratory conditions, but users should follow the manufacturer’s instructions for avoiding contamination and maintaining material integrity during fabrication.