Heliotint

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

510(k) Number

K901918 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• D-Sign VI (R&D Project DW266#9)

  Class II

  FDA 510(k) K990235 Active Cleared 1 Mar 1999

• Biouniversal Pdf

  Class II

  FDA 510(k) K011022 Active Cleared 2 May 2001

• Fermit N Plus

  Class II

  FDA 510(k) K003377 Active Cleared 4 Dec 2000

• Tetric Flow

  Class II

  FDA 510(k) K993783 Active Cleared 13 Dec 1999

• Sr-Isosit Spectra Link System

  Class II

  FDA 510(k) K910069 Active Cleared 2 Mar 1992

• Basic Calcium Hydroxide Liner

  Class II

  FDA 510(k) K896529 Active Cleared 16 Jan 1990

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• What is Heliotint used for in dental restorations and how does it improve the appearance of teeth?

  Heliotint is a dental tinting agent designed to enhance the aesthetic appearance of dental restorations by providing a uniform tint. It helps match the natural tooth color, ensuring better visual integration with restorative treatments like fillings or crowns. This improves the overall look and blending of dental work with the patient’s existing teeth.

• Is Heliotint intended for single-use or can it be reused in a clinical setting?

  Heliotint is explicitly supplied as a single-use tinting solution, meaning each package is meant for one application only. This design ensures sterility and consistency of results, as reuse could compromise the product’s integrity and safety in dental procedures.

• How is Heliotint packaged, and is it sterile for direct clinical use?

  Heliotint is packaged in a manner suitable for clinical use but is not sterile. The packaging is designed to protect the tinting solution during handling in a dental office, though it does not meet the standards for sterile medical devices. Clinicians should follow standard aseptic techniques when using it.

• What regulatory pathway was followed for Heliotint’s FDA clearance, and what does that mean for its use?

  Heliotint received FDA clearance through a 510(k) submission (K901918), classified under product code EBF for dental tinting agents. The device was deemed substantially equivalent to a legally marketed predicate, meaning it was evaluated for safety and effectiveness based on existing dental tinting solutions. This clearance allows licensed dental professionals to use it in offices for its intended aesthetic purposes.