IPS Empress Direct Flow

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

510(k) Number

K103528 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ips E.max Cad/Ips E.max Zircad Open recall

  Class II

  FDA 510(k) K051705 Active Cleared 14 Oct 2005

• Empress Direct

  Class II

  FDA 510(k) K090701 Active Cleared 29 Apr 2009

• Adhese 2

  Class II

  FDA 510(k) K252450 Active Cleared 5 Mar 2026

• Tetric Evoceram

  Class II

  FDA 510(k) K042819 Active Cleared 9 Nov 2004

• Tetric plus Fill

  Class II

  FDA 510(k) K261485 Active Cleared 1 Jul 2026

• Bluephase

  Class II

  FDA 510(k) K033520 Active Cleared 5 Dec 2003

See all devices from Ivoclar Vivadent, Inc. →

• What types of dental restorations is the IPS Empress Direct Flow intended for, and how does its flowable consistency help in these applications?

  The IPS Empress Direct Flow is designed for direct dental restorations, specifically for both anterior (front) and posterior (back) teeth fillings. Its flowable consistency allows it to easily adapt to the natural anatomical contours of teeth, including intricate details like occlusal pits and fissures, while also replicating aesthetic qualities such as opalescence and translucency. This makes it ideal for creating seamless, natural-looking restorations that blend with existing tooth structure.

• How many shade options are available for the IPS Empress Direct Flow, and what are they intended to achieve?

  The IPS Empress Direct Flow comes in multiple shades, including Trans Opal, Trans 30, and Bleach XL. These options are specifically formulated to closely match the natural color variations of teeth, ensuring restorations appear lifelike and harmonious with the patient’s existing dentition. The shades help clinicians achieve a more aesthetically pleasing result, particularly in cases where tooth discoloration or bleaching has occurred.

• Is the IPS Empress Direct Flow intended for single-use or can it be reused after opening?

  The provided data does not explicitly state whether the IPS Empress Direct Flow is sterile or intended for single-use. Typically, dental composites like this are not sterile and are designed for reuse within a clinical setting, provided proper infection control protocols are followed. Clinicians should adhere to standard dental hygiene practices, such as using sterile instruments and maintaining a clean workspace, to ensure safe and effective use.

• What regulatory pathway was followed for the FDA clearance of the IPS Empress Direct Flow, and what does this mean for its use in dental practices?

  The IPS Empress Direct Flow received FDA clearance through a 510(k) Traditional pathway under the product code EBF (Dental Restorative Materials). This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device in terms of technology and intended use. Clinicians can use it with confidence, knowing it meets FDA standards for safety and effectiveness as a dental composite resin for direct restorations.