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Telio CS Cem Implant

by Ivoclar Vivadent AG

510(k) K120432

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120432 Date8 Jun 2012ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EMA
FDA applicant
Ivoclar Vivadent, AG
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Telio CS Cem Implant is a dental cement designed for reversible or semi-permanent cementation of long-term temporary and permanent restorations on implant abutments. It falls under the classification of dental cement, formulated to provide a durable bond in restorative dentistry applications.

This product is supplied as a multi-component system, intended for use in clinical settings by dental professionals. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The material composition includes bismethacrylates, fillers, initiators, stabilizers, auxiliaries, and pigments, with no specific sterility or single-use designation noted in the data. Storage and handling instructions are detailed in the accompanying user manual.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Telio CS Cem Implant primarily used for in dental procedures?

    The Telio CS Cem Implant is designed specifically for the reversible or semi-permanent cementation of long-term temporary and permanent restorations on implant abutments. This makes it ideal for securing crowns, bridges, or other dental prosthetics in restorative dentistry where a durable bond is required.

  • Is the Telio CS Cem Implant intended for single-use or can it be reused?

    The provided data does not explicitly state whether the Telio CS Cem Implant is single-use or reusable. However, since it is a multi-component dental cement intended for clinical use, it is typically designed for single applications per package. For precise usage instructions, refer to the accompanying user manual.

  • How is the Telio CS Cem Implant supplied, and what should I consider when storing it?

    The Telio CS Cem Implant is supplied as a multi-component system, meaning it likely comes in separate containers for the base and catalyst or other required components. Storage instructions are detailed in the user manual, which should specify conditions like temperature, humidity, and light exposure to maintain product integrity.

  • What regulatory pathway was followed for the FDA clearance of the Telio CS Cem Implant?

    The Telio CS Cem Implant received FDA clearance through a 510(k) Traditional pathway, classified as a Class II medical device under FDA regulations. The submission was filed under the Dental advisory committee (DE) and was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE.