Skip to content

Tokuyama CureGrace

by Tokuyama Dental Corporation

510(k) K170549

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 NumberK170549 Date5 Jul 2017ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA product code
EBI
Device class
Class II
Regulation
21 CFR Part 872.3760
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 Tokuyama CureGrace is a dental adhesive resin composite designed for restorative and aesthetic dental applications. It is classified under the product code EBI, indicating its use in bonding and filling procedures to restore tooth structure while maintaining natural appearance.

This device is supplied as a single-use, non-sterile kit intended for use in dental offices. It is cleared by the FDA under 510(k) number K170549 as substantially equivalent to a predicate device, adhering to traditional review standards. Storage and handling follow standard dental material protocols, with no specific MRI safety considerations noted.

Other devices from Tokuyama Dental Corporation

See all devices from Tokuyama Dental Corporation →

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 types of dental procedures is the Tokuyama CureGrace adhesive resin composite intended for?

    The Tokuyama CureGrace is specifically designed for restorative and aesthetic dental applications, particularly for bonding and filling procedures. It is used to restore tooth structure while maintaining a natural appearance, making it suitable for filling cavities, repairing minor fractures, or enhancing the look of teeth.

  • Is the Tokuyama CureGrace kit single-use or reusable, and how should it be stored?

    The Tokuyama CureGrace is supplied as a single-use, non-sterile kit, meaning each kit is intended for one-time use in a dental office. Storage follows standard dental material protocols, though no specific instructions beyond typical dental adhesive handling are provided in the data.

  • What regulatory pathway did Tokuyama Dental Corporation follow to clear the Tokuyama CureGrace in the U.S.?

    Tokuyama Dental Corporation cleared the Tokuyama CureGrace through the FDA’s 510(k) process, specifically under the traditional review pathway. The device was determined to be substantially equivalent to a predicate, receiving clearance under 510(k) number K170549 on July 5, 2017.

  • Are there any special handling considerations for the Tokuyama CureGrace, such as MRI safety?

    The Tokuyama CureGrace does not have any specific MRI safety considerations noted in the provided data. It should be handled according to standard dental material protocols, and no additional precautions beyond typical adhesive resin composite usage are mentioned.