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Palfique Estelite Paste

by Tokuyama America, Inc.

510(k) K980051

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 NumberK980051 Date24 Feb 1998ClearedStatusActive

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  • Withdrawn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
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

PALFIQUE ESTELITE PASTE is a tooth shade resin material used in dental procedures. It is classified under product code EBF and was determined to be substantially equivalent to a predicate device.

The device received traditional 510(k) clearance from the FDA on February 24, 1998, under K980051. It is manufactured by Tokuyama America, Inc. and is intended for use in dental applications as a resin-based tooth shade material.

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Questions

AI-generated answers, 25 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 PALFIQUE ESTELITE PASTE used for?

    PALFIQUE ESTELITE PASTE is a tooth shade resin material intended for use in dental procedures as a resin-based tooth shade material, designed to match natural tooth color during restorative treatments.

  • How is PALFIQUE ESTELITE PASTE supplied and is it sterile or single-use?

    The device data does not specify sterility, single-use status, or supply format for PALFIQUE ESTELITE PASTE; therefore, no claims about sterility or reuse can be made based on the provided information.

  • What regulatory pathway was used for PALFIQUE ESTELITE PASTE and when was it cleared?

    PALFIQUE ESTELITE PASTE received traditional 510(k) clearance from the FDA on February 24, 1998, under submission K980051, demonstrating substantial equivalence to a predicate device under product code EBF.