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FLNT Base and FLNT Temp

by Liaoning Upcera Co., Ltd.

510(k) K253380

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253380 Date2 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
EBG
Device class
Class II
Regulation
21 CFR Part 872.3770
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

Flnt Base and Flnt Temp are dental devices classified as temporary crown and bridge resin. These materials are intended for use in the fabrication of temporary dental restorations.

This device is manufactured by Liaoning Upcera Co., Ltd. and has received FDA 510(k) clearance under K253380. It is regulated as a Class 2 dental device under 21 CFR 872.3770.

Other devices from Liaoning Upcera Co., Ltd.

See all devices from Liaoning Upcera Co., Ltd. →

Questions

AI-generated answers, 21 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 are FLNT Base and FLNT Temp used for?

    These materials are dental resins specifically intended for the fabrication of temporary crown and bridge restorations. They serve as a temporary solution for patients during the interim period before a permanent restoration is placed.

  • Who is the manufacturer of these dental resins?

    FLNT Base and FLNT Temp are manufactured by Liaoning Upcera Co., Ltd., located in Benxi, China.

  • What is the regulatory status of these devices?

    These devices have received FDA 510(k) clearance under K253380. They are regulated as Class 2 dental devices under 21 CFR 872.3770, which classifies them as temporary crown and bridge resins.