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Celtra Press

by Dentsply Sirona 510(k)

Active United States

510(k) K161269

Overview

The Celtra Press is an all-ceramic system used for the creation of various dental restorations, including Occlusal veneers, Thin veneers, Veneers, Inlays, Onlays, Crowns, and 3-unit bridges. It is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals. The Celtra Press is designed to provide a natural-like appearance with excellent VITA shade matching and a balance of translucency and natural opalescence.

The Celtra Press is supplied as a dental restoration system and is intended for use in the creation of various dental restorations. It has received FDA 510K authorization and has been classified under product code EIH. The system is designed to provide a natural-like appearance and is suitable for use in the anterior and posterior regions.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161269 Date12 Aug 2016ClearedStatusActive

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
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Celtra Press used for?

    The Celtra Press is used for creating various dental restorations, including Occlusal veneers, Thin veneers, Veneers, Inlays, Onlays, Crowns, and 3-unit bridges, providing a natural-like appearance.

  • What is the composition of the Celtra Press?

    The Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals, designed to provide a balance of translucency and natural opalescence.

  • Is the Celtra Press suitable for use in all regions of the mouth?

    Yes, the Celtra Press is suitable for use in both the anterior and posterior regions of the mouth.

  • What regulatory authorization has the Celtra Press received?

    The Celtra Press has received FDA 510K authorization, classified under product code EIH, and has been determined to be substantially equivalent.