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Chronos-Beta-TCP

by Synthes (Usa) 510(k)

Active United States

510(k) K053022

Overview

Chronos-Beta-TCP is a synthetic bone grafting material composed of beta-tricalcium phosphate (β-TCP). It functions as an osteoconductive scaffold designed to support bone regeneration by promoting the growth of new bone tissue during the healing process. The porous structure facilitates cellular infiltration and integration with surrounding bone, aiding in defect reconstruction in dental applications. This material is intended for use in procedures requiring controlled bone regeneration, such as alveolar ridge augmentation or socket preservation.

This device is supplied as a single-use, non-sterile material that requires sterilization prior to use, typically via gamma irradiation. It is classified under product code LYC as a Class II device under FDA regulations, with a clearance decision dated January 23, 2006, deemed Substantially Equivalent (SESE). Chronos-Beta-TCP is intended for dental applications and is packaged in various sizes and formulations, as indicated by the associated registration numbers. No MRI safety information is specified, and it is not intended for reusable applications.

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 · Traditional NumberK053022 Date23 Jan 2006ClearedStatusActive

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
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  • 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)

Full name
Synthes (USA) Chronos-Beta-Tcp
510(k) Number
FDA Product Code
LYC
Device Class
Class II
Regulation
21 CFR Part 872.3930
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

Questions

  • What is Chronos-Beta-TCP used for in dental procedures?

    Chronos-Beta-TCP is a synthetic bone grafting material composed of beta-tricalcium phosphate (β-TCP), designed to support bone regeneration. It acts as an osteoconductive scaffold, promoting new bone growth during healing. This makes it ideal for procedures like alveolar ridge augmentation or socket preservation, where controlled bone regeneration is required to reconstruct defects.

  • Is Chronos-Beta-TCP sterile when supplied, and how should it be prepared for use?

    Chronos-Beta-TCP is supplied in a non-sterile state and requires sterilization prior to use. The recommended method for sterilization is gamma irradiation, which ensures the material is safe for clinical application before being used in dental procedures.

  • Is Chronos-Beta-TCP intended for single-use or reusable applications?

    Chronos-Beta-TCP is explicitly designed for single-use only. It is not intended for reuse, as its composition and sterilization process are tailored for one-time clinical application in bone grafting procedures.

  • What sizes or formulations are available for Chronos-Beta-TCP?

    Chronos-Beta-TCP is available in multiple sizes and formulations, each identified by specific registration numbers. These variations cater to different clinical needs, such as varying defect sizes or procedural requirements in dental applications. For precise sizing, refer to the product documentation or contact the manufacturer.

  • How should Chronos-Beta-TCP be stored before use?

    While the specific storage instructions are not detailed in the provided data, non-sterile bone grafting materials like Chronos-Beta-TCP are generally stored in a clean, dry environment protected from moisture and contamination. Ensure the packaging remains intact until sterilization is performed prior to use.