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Permalute Try-In Paste

by Ultradent Products, Inc.

510(k) K971898

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 NumberK971898 Date24 Jun 1997ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

Permalute Try-In Paste is a dental material designed for clinicians to preview the shade of a final restoration. The paste is applied to the restoration prior to permanent cementation to allow for the visualization of the color match.

This water-soluble and reversible paste is intended for easy removal and cleaning before the final bonding procedure. The device is authorized under FDA 510(k) K971898.

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Questions

AI-generated answers, 6 Oct 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 the purpose of Permalute Try-In Paste?

    Permalute Try-In Paste is a dental material used by clinicians to preview the shade of a final restoration before permanent cementation, ensuring an accurate color match.

  • How is the paste removed after use?

    The paste is water-soluble and reversible, which allows for easy removal and cleaning from the restoration surface before the final bonding procedure is performed.

  • What is the regulatory status of this dental material?

    Permalute Try-In Paste is authorized under FDA 510(k) K971898, which confirms its status as a substantially equivalent dental device.