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els Unibond

by Saremco Dental AG Switzerland 510(k)

510(k) K252151 Product code KLE

Overview

The els Unibond is a Tooth Bonding Agent, Resin, classified as a dental adhesive. It is designed to create a durable, gap-free bond between dental hard tissue and light-curing restorative or fixing materials, ensuring long-term adhesion in restorative dentistry.

This single-component, self-etching adhesive is light-cured and intended for use in clinical settings. Supplied as a sterile, single-use product, it is regulated under FDA 510(k) clearance (K252151) and falls under the Dental advisory committee classification. It is non-reusable and must be stored according to manufacturer guidelines to maintain integrity.

Summary written by AI from registry data, 19 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 · Traditional NumberK252151 Date5 Dec 2025ClearedStatusActive

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
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
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 Unibond used for in clinical practice?

    The els Unibond is a dental adhesive designed to create a strong, gap-free bond between dental hard tissue (like enamel or dentin) and light-curing restorative or fixing materials. It ensures long-term adhesion in restorative dentistry procedures, such as bonding fillings, crowns, or other dental restorations.

  • Is the els Unibond reusable or single-use, and how should it be stored?

    The els Unibond is a single-use product, meaning each application requires a new unit. To maintain its integrity, it must be stored according to the manufacturer’s guidelines, which are provided by Saremco Dental AG.

  • What type of curing process does the els Unibond require, and is it sterile?

    The els Unibond is a single-component, self-etching adhesive that requires light-curing to activate. It is supplied in a sterile packaging, ensuring it is ready for immediate clinical use without additional sterilization.

  • How is the els Unibond regulated, and what does that mean for its use?

    The els Unibond is regulated under the FDA’s 510(k) clearance process (K252151) and is classified under the Dental advisory committee. This means it has been deemed substantially equivalent to a predicate device and is approved for use in clinical settings as a dental adhesive, adhering to strict regulatory standards.

  • Are there different sizes or models of the els Unibond, or is it available in a single formulation?

    The provided data does not specify multiple sizes or models for the els Unibond. It is described as a single-component adhesive, implying a uniform formulation. For exact details on packaging or variants, refer to the manufacturer’s documentation.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K252151 24 fields · synced 22 Oct 2026