Flow Line

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K990756 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Heraeus Kulzer, Inc. →

• What is the Flow Line used for in dental procedures?

  The Flow Line is a resin-based composite specifically designed to restore and match the natural color of teeth, providing durable and aesthetically pleasing dental restorations. It is intended for tooth shade applications where blending with existing teeth is critical.

• Is the Flow Line meant for single-use or can it be reused?

  The Flow Line is explicitly supplied for single-use applications in clinical settings. This ensures sterility and safety for each patient, as reuse could compromise material integrity and infection control.

• How was the Flow Line’s regulatory approval process handled by the FDA?

  The Flow Line received FDA clearance through the Traditional 510(k) Review process, with a decision date of May 7, 1999. It was determined to be substantially equivalent to a legally marketed predicate device under product code EBF, which classifies it as a dental material for tooth shade applications.

• What classification does the Flow Line fall under in regulatory terms?

  The Flow Line is classified under the regulatory name 'Material, Tooth Shade, Resin' and is assigned product code EBF. This classification reflects its purpose as a resin-based composite for dental restorations focused on matching natural tooth color.