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TPH Spectra ST Flowable Composite Restorative

by Dentsply Sirona 510(k)

Active United States

510(k) K182288

Overview

TPH Spectra ST Flowable Composite Restorative is a visible light cured flowable composite resin restorative material. It is designed for enhanced simplicity and versatility in esthetic flowable applications.

It is indicated for use in all traditional flowable indications including anterior and posterior teeth for direct restoration of cavities (except occlusal stress bearing Class II cavities), lesions, and build-up of teeth. The device is supplied as a restorative material and is regulated under FDA 510(k) clearance K182288 with product code EBF.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182288 Date20 Nov 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is TPH Spectra ST Flowable Composite Restorative used for?

    It is indicated for use in all traditional flowable indications including anterior and posterior teeth for direct restoration of cavities (except occlusal stress bearing Class II cavities), lesions, and build-up of teeth. This makes it suitable for esthetic flowable applications where high strength is not required on biting surfaces.

  • How is TPH Spectra ST Flowable Composite Restorative supplied and cured?

    The device is supplied as a restorative material and is a visible light cured flowable composite resin. It requires exposure to visible light to polymerize and harden after placement in the tooth cavity.

  • What regulatory pathway was used for TPH Spectra ST Flowable Composite Restorative?

    The device received FDA 510(k) clearance under submission K182288 and is regulated under product code EBF. The decision was based on a finding of substantial equivalence to a predicate device.