Enaden Flow

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

510(k) Number

K140976 ↗

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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• What types of dental cavities is the Enaden Flow specifically designed to restore, and how does its flowable nature help in the process?

  The Enaden Flow is designed to restore occlusal surfaces, pits, fissures, and Class II and V cavities with minimal tooth reduction. Its flowable polymer-based composition allows it to adapt easily to the contours of the cavity, filling gaps and intricate areas more effectively than traditional composites. This makes it ideal for scenarios where precision and minimal material waste are important.

• How is the Enaden Flow supplied, and what precautions should be taken during handling to ensure proper use?

  The Enaden Flow comes in a plastic syringe with a plunger, disposable needle, and protective cap, all intended for single-use in dental settings. Since it is a single-use device, it should not be reused after application. The protective cap ensures sterility until use, and the disposable needle prevents cross-contamination. Always follow standard dental composite protocols for storage, including keeping it in a clean, dry environment away from direct sunlight or extreme temperatures.

• Is the Enaden Flow compatible with MRI procedures, and if not, why?

  No, the Enaden Flow is explicitly not intended for MRI use. This is because the polymer-based material may contain components that could interact with magnetic fields, posing a risk to both the patient and the imaging equipment. Always verify compatibility with any planned MRI procedures before using the material.

• What curing method is required for the Enaden Flow, and how does this affect its application in a clinical setting?

  The Enaden Flow requires visible light activation for curing, meaning it must be exposed to a dental curing light to harden properly. This method allows for precise control over the curing process, ensuring optimal adhesion and setting time. Clinicians should use a compatible visible light source and follow manufacturer guidelines for exposure duration to achieve the best results.

• What regulatory pathway was followed for FDA clearance of the Enaden Flow, and what does this mean for its safety and effectiveness?

  The Enaden Flow received FDA clearance through a traditional 510(k) review pathway under Product Code EBF (Dental Materials), with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards. The clearance was granted by the Dental (DE) Advisory Committee in 2014, confirming its compliance with regulatory requirements.