Skip to content

CEREC Tessera Abutment Block

by Dentsply Sirona, Inc.

510(k) K221402

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 NumberK221402 Date22 Mar 2023ClearedStatusActive

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  • Withdrawn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)

Full name
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
510(k) Number
FDA Product Code
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 CEREC Tessera Abutment Block is a dental CAD/CAM ceramic block designed for the fabrication of custom abutments in implant dentistry. It is part of the CEREC Tessera Abutment System and serves as a substrate for creating abutments that can be cemented to an implant system intraorally, enabling precise restoration of dental implants.

This block is used in a chairside workflow where it is milled or shaped extraorally to form an abutment, which is then cemented to a TiBase and screwed into an implant system. Supplied as a reusable ceramic component, it requires proper handling and sterilization procedures as dictated by dental protocols. The device is authorized under FDA 510(k) clearance (K221402) and is classified under product code NHA for dental use.

Other devices from Dentsply Sirona Inc

See all devices from Dentsply Sirona Inc →

Questions

AI-generated answers, 19 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 CEREC Tessera Abutment Block used for in dental implant procedures?

    The CEREC Tessera Abutment Block is specifically designed for chairside CAD/CAM milling to create custom ceramic abutments in implant dentistry. These abutments are then cemented to a TiBase and screwed into an implant system, allowing for precise and tailored dental restorations. It streamlines the workflow by enabling same-day fabrication of abutments tailored to individual patient needs.

  • How is the CEREC Tessera Abutment Block supplied, and is it single-use or reusable?

    The CEREC Tessera Abutment Block is supplied as a reusable ceramic component, meaning it can be used multiple times for milling custom abutments. However, it requires proper handling and sterilization following dental protocols to maintain its integrity and prevent cross-contamination between patients.

  • What regulatory pathway was followed for FDA clearance of this device?

    The CEREC Tessera Abutment Block received FDA clearance through a 510(k) submission (K221402), classified under product code NHA for dental use. The device was determined to be substantially equivalent to a legally marketed predicate, following a traditional review process by the Dental (DE) Advisory Committee. The clearance was finalized on March 22, 2023.

  • Can you explain the workflow for using the CEREC Tessera Abutment Block in a clinical setting?

    The workflow involves milling or shaping the reusable ceramic block extraorally using CAD/CAM technology to create a custom abutment. Once milled, the abutment is cemented to a TiBase and then screwed into the implant system intraorally. This process ensures a precise fit for dental restoration, leveraging the block’s versatility for chairside fabrication without the need for multiple visits.