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FormCore DC, Model 28-700100

by J. Morita U.S.A., Inc

510(k) K061664

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061664 Date8 Sep 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 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  • Withdrawn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
EBF
FDA applicant
J. Morita USA, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3690
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.

FormCore DC is a dual-cure core buildup material used in dental procedures. It is a composite-based material that can be cured either by a dental curing light or through self-cure mechanisms.

The device is supplied as a complete kit containing an auto-mix mini syringe (5 mL), 10 intraoral tips, and 10 mixing tips. It is available in shade A3 and has a light cure set time of 40 seconds and a self-cure set time of 3 minutes. The product is authorized under FDA 510(k) clearance K061664 with product code EBF.

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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 FormCore DC used for in dental procedures?

    FormCore DC is a dual-cure core buildup material used in dental procedures. It is a composite-based material that can be cured either by a dental curing light or through self-cure mechanisms, making it versatile for various dental applications.

  • How is FormCore DC supplied and what does the kit include?

    FormCore DC is supplied as a complete kit containing an auto-mix mini syringe (5 mL), 10 intraoral tips, and 10 mixing tips. The kit provides everything needed for proper application and mixing of the material during dental procedures.

  • What are the cure times for FormCore DC and in which shade is it available?

    FormCore DC has a light cure set time of 40 seconds and a self-cure set time of 3 minutes. It is available in shade A3, which is a common dental shade that matches natural tooth color for aesthetic restorations.

  • What is the regulatory status of FormCore DC?

    FormCore DC is authorized under FDA 510(k) clearance K061664 with product code EBF. This clearance indicates that the device is substantially equivalent to other legally marketed devices in the United States.