Variolink Esthetic

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

510(k) Number

K142389 ↗

FDA product code

EBF

FDA applicant

Ivoclar Vivadent, AG

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 Ivoclar Vivadent AG →

• What types of dental restorations is Variolink Esthetic specifically designed to bond with, and why is this important for clinicians?

  Variolink Esthetic is formulated to permanently cement ceramic and composite resin restorations that require high esthetic standards. This is important for clinicians because it ensures strong adhesion and a natural appearance, reducing the risk of discoloration or failure over time, which is critical for long-term patient satisfaction and restoration integrity.

• How is Variolink Esthetic supplied, and what preparation is required before use?

  Variolink Esthetic comes as a two-paste system, meaning the two components must be mixed together before application. This ensures proper curing and bonding properties. Since it is single-use and must be handled under aseptic conditions, clinicians should follow strict sterile techniques to prevent contamination and ensure patient safety.

• Is Variolink Esthetic reusable, or is it intended for one-time use per patient?

  Variolink Esthetic is explicitly designed for single-use only. This is a standard practice for dental adhesives to maintain sterility and prevent cross-contamination between patients, ensuring both safety and effectiveness in clinical settings.

• Does Variolink Esthetic have any specific storage requirements, and where can I find detailed instructions?

  While the exact storage conditions are not detailed here, the manufacturer’s technical documentation—available through Ivoclar Vivadent—provides specific guidance on storage to preserve the product’s integrity. Proper storage is essential to maintain the material’s curing properties and shelf life, so always refer to the official documentation for precise instructions.

• What regulatory pathway was followed for Variolink Esthetic’s FDA clearance, and how does this affect its use in clinical practice?

  Variolink Esthetic received FDA clearance through an abbreviated 510(k) process, determined to be substantially equivalent to a predicate device under product code EBF (Dental Adhesive Cements). This means it meets established safety and performance standards for dental adhesives, allowing clinicians to rely on its efficacy and compliance with U.S. regulatory requirements for permanent cementation of indirect restorations.