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Els Extra Low Shrinkage Composite & Els Extra Low Shrinkage Flow

by Saremco Dental AG Switzerland 510(k)

510(k) K240823 Product code EBF

Overview

The Els Extra Low Shrinkage Composite & Els Extra Low Shrinkage Flow is a dental composite material, specifically a microhybrid composite, designed for use in dental restorations. It is characterized by its extremely low shrinkage stress and good marginal seal. The composite is free from TEGDMA and HEMA, and features low water absorption and solubility, making it suitable for various dental applications.

The Els Extra Low Shrinkage Composite & Els Extra Low Shrinkage Flow is supplied in a syringe and is intended for light-curing. It is available in a range of shades and is designed for use in the front and other areas of the mouth. The device has received FDA 510K authorization, indicating substantial equivalence to a predicate device. The manufacturer, Saremco Dental AG, provides instructions for use, which are available in a PDF format.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK240823 Date27 Jun 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Saremco Dental AG

See all devices from Saremco Dental AG →

Questions

  • What is the Els Extra Low Shrinkage Composite & Flow used for?

    The Els Extra Low Shrinkage Composite & Flow is used for dental restorations, specifically in the front and other areas of the mouth, due to its low shrinkage stress and good marginal seal.

  • How is the Els Extra Low Shrinkage Composite & Flow supplied?

    The Els Extra Low Shrinkage Composite & Flow is supplied in a syringe and is intended for light-curing, making it convenient for dental applications.

  • Is the Els Extra Low Shrinkage Composite & Flow suitable for patients with sensitivity?

    The Els Extra Low Shrinkage Composite & Flow is free from TEGDMA and HEMA, and features low water absorption and solubility, making it a suitable option for various dental applications, including patients with sensitivity.

  • What shades is the Els Extra Low Shrinkage Composite & Flow available in?

    The Els Extra Low Shrinkage Composite & Flow is available in a range of shades, allowing for a natural-looking dental restoration.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K240823 24 fields · synced 22 Oct 2026