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Ceramir Crown & Bridge

by Doxa AB 510(k)

Active United States

510(k) K100510

Overview

The Ceramir Crown & Bridge is a bioceramic luting cement designed for permanent cementation of dental prosthetics. It is specifically formulated to secure conventional crowns and bridges, including all-ceramic restorations on aluminum oxide or zirconium dioxide frameworks, ensuring durable and biocompatible fixation.

This product is supplied as a reusable dental cement, intended for use in clinical settings by dental professionals. It is classified as a Class II device under FDA regulations (K100510) and adheres to dental cementation standards. The material is packaged for single-use applications per procedure, with no MRI safety restrictions noted. Storage follows standard dental adhesive protocols, and its regulatory authorization includes FDA 510(k) clearance.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK100510 Date25 Mar 2010ClearedStatusActive

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

Questions

  • What is the Ceramir Crown & Bridge cement used for?

    The Ceramir Crown & Bridge is a bioceramic luting cement specifically formulated for the permanent cementation of dental prosthetics. It is designed to securely fix conventional crowns and bridges, including all-ceramic restorations on aluminum oxide or zirconium dioxide frameworks, ensuring durable and biocompatible fixation.

  • Is the Ceramir Crown & Bridge cement reusable or single-use?

    The Ceramir Crown & Bridge cement is supplied for single-use per clinical procedure. Each package is intended to be used once, ensuring sterility and compliance with dental cementation standards.

  • How should the Ceramir Crown & Bridge cement be stored?

    Storage follows standard dental adhesive protocols. The product should be kept in a clean, dry environment, protected from extreme temperatures and direct sunlight, to maintain its integrity and effectiveness.

  • Does the Ceramir Crown & Bridge cement have any MRI safety restrictions?

    No MRI safety restrictions are noted for the Ceramir Crown & Bridge cement. This means it can be used in patients who require MRI scans without additional concerns related to the cement itself.

  • What regulatory authorization does the Ceramir Crown & Bridge cement have?

    The Ceramir Crown & Bridge cement holds FDA 510(k) clearance, confirming it meets regulatory standards for dental luting cements in the United States. It is classified as a Class II device under FDA regulations.