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Vertex Rapid Simplified

by Vertex-Dental B.V.

510(k) K102654

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 NumberK102654 Date3 Dec 2010ClearedStatusActive

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  • Withdrawn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
EBI
Device class
Class II
Regulation
21 CFR Part 872.3760
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Vertex Rapid Simplified is a heat-curing denture base material that forms a solid base for full and partial dentures. It is a polymer used in the fabrication of dentures and is characterized by excellent mechanical properties and flexibility during processing.

The device is supplied as a polymer (e.g., 500g) and liquid (e.g., 1000ml bottle) for use in dental laboratories. It is processed using the pressing technique and is intended for the construction of full and partial dentures. Authorization is based on FDA 510(k) clearance under product code EBI, with a decision of substantially equivalent.

Other devices from Vertex-Dental B.V.

See all devices from Vertex-Dental B.V. →

Questions

AI-generated answers, 26 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 Vertex Rapid Simplified used for?

    Vertex Rapid Simplified is a heat-curing denture base material used to form solid bases for full and partial dentures, offering excellent mechanical properties and flexibility during processing in dental laboratories.

  • How is Vertex Rapid Simplified supplied and processed?

    The device is supplied as a polymer (e.g., 500g) and liquid (e.g., 1000ml bottle) and is processed using the pressing technique in dental laboratories to construct denture bases.

  • Is Vertex Rapid Simplified intended for single-use or reuse?

    Vertex Rapid Simplified is a material used in the fabrication process and is not a final implanted or reusable device; once cured into a denture base, it becomes part of a final prosthetic device intended for long-term patient use.

  • What regulatory pathway was used for Vertex Rapid Simplified?

    Vertex Rapid Simplified received FDA 510(k) clearance under product code EBI, with a determination of substantially equivalent to a predicate device, based on a traditional review process.