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Calibra Abutment Resin Cement

by Dentsply Sirona 510(k)

Active United States

510(k) K240888

Overview

Calibra Abutment Resin Cement is a dental cement used for securing abutments in dental implant procedures. It is a resin-based cement designed to provide strong adhesion between dental components.

The device is supplied as a single-use product and is regulated under FDA 510K clearance with product code EMA. It is manufactured by Dentsply Sirona and is classified as a Class II dental cement. The device is not indicated for MRI use and should be stored according to manufacturer instructions.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK240888 Date2 Apr 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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Other devices from Dentsply Sirona Inc

See all devices from Dentsply Sirona Inc →

Questions

  • What is Calibra Abutment Resin Cement used for?

    Calibra Abutment Resin Cement is a dental cement specifically designed for securing abutments in dental implant procedures. It provides strong adhesion between dental components to ensure proper placement and stability of the implant structure.

  • Is Calibra Abutment Resin Cement a single-use product?

    Yes, Calibra Abutment Resin Cement is supplied as a single-use product. This means it should be used for one patient procedure only and not reused or resterilized to maintain safety and effectiveness.

  • How should Calibra Abutment Resin Cement be stored?

    The device should be stored according to the manufacturer's instructions. While specific storage details aren't provided in the data, it's important to follow the manufacturer's guidelines to maintain the product's integrity and performance.

  • What is the regulatory status of Calibra Abutment Resin Cement?

    Calibra Abutment Resin Cement is regulated under FDA 510K clearance with product code EMA. It is classified as a Class II dental cement and received special clearance as substantially equivalent to predicate devices.