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Premise Flowable

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060472

by Kerr Corporation

Identifiers

510(k) Number
K060472 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Premise Flowable is a flowable light-cure composite resin, classified as a dental restorative material under the FDA’s dental product category. It is designed to provide a low-viscosity alternative to traditional composites, facilitating precise placement and contouring in restorative procedures.

This material is supplied as a single-use, non-sterile dental product intended for use in clinical settings by dental professionals. It requires light activation for curing and is available in a specific product code (EBF) under FDA 510(k) clearance (K060472). Storage and handling follow standard dental composite protocols, with no noted MRI compatibility restrictions.

Frequently asked questions

What type of dental material is Premise Flowable and how is it intended to be used?

Premise Flowable is described as a flowable light‑cure composite resin, which places it in the dental restorative material category. The description states it is a low‑viscosity alternative to traditional composites, meaning it is meant to be placed and then cured with a dental curing light during restorative procedures.

Is Premise Flowable supplied sterile and can it be reused?

The device data specifies that Premise Flowable is supplied as a single‑use, non‑sterile product. Because it is labeled single‑use, it is intended to be discarded after one patient encounter and not reprocessed for reuse.

How should Premise Flowable be stored and handled before use?

The data notes that storage and handling follow standard dental composite protocols, which typically involve keeping the material in a cool, dry place, protecting it from premature light exposure, and using it within the manufacturer’s recommended shelf life. No special MRI compatibility concerns are mentioned.

What regulatory pathway did Premise Flowable follow to reach the market?

Premise Flowable received FDA 510(k) clearance (K060472) under the product code EBF, as indicated by the authorization and decision description. This means the manufacturer demonstrated that the product is substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the United States.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Premise™ Flowable Flowable Light Cure Composite | Kerr Dental, Premise Flowable | Kerr Dental, Flowable composite dental material - Premise™ Flowable - Kerr ..., Kerr Premise Flowable - Amtouch Dental Supply

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kerr Corporation

Sources (1)

  • FDA 510(k) K060472 24 fields · synced Sep 19, 2026