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Tokuyama Bond Force

by Tokuyama Dental Corporation

510(k) K070215

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 NumberK070215 Date30 Mar 2007ClearedStatusActive

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  • Withdrawn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
KLE
Device class
Class II
Regulation
21 CFR Part 872.3200
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Tokuyama Bond Force is a dental bonding agent used for tooth bonding with resin. It is designed to adhere dental materials to tooth surfaces.

The device is supplied by Tokuyama Dental Corporation and is authorized under FDA 510K clearance. It is a Class II device with product code KLE and is intended for dental use.

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Questions

AI-generated answers, 23 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 Tokuyama Bond Force used for?

    Tokuyama Bond Force is a dental bonding agent designed to adhere dental materials, specifically resin, to tooth surfaces for tooth bonding procedures.

  • How is Tokuyama Bond Force supplied and by whom?

    Tokuyama Bond Force is supplied by Tokuyama Dental Corporation, located at 1425 K St., NW, Suite 1100, Washington, DC 20005, United States.

  • Is Tokuyama Bond Force a single-use or reusable device?

    The device data does not specify whether Tokuyama Bond Force is single-use or reusable; therefore, reuse status cannot be determined from the provided information.

  • What regulatory pathway was used for Tokuyama Bond Force?

    Tokuyama Bond Force received FDA 510K clearance under submission number K070215, with a decision date of March 30, 2007, and is classified as a Class II device with product code KLE.

  • What are the key identifiers for Tokuyama Bond Force in regulatory databases?

    Tokuyama Bond Force is identified by device name TOKUYAMA BOND FORCE, K-number K070215, product code KLE, and regulation number 872.3200, with FEI and registration numbers listed in the OpenFDA data.