TPH Spectra ST Flowable Composite Restorative— 510(k) K182288

Name: FDA 510(k) clearance K182288
Creator: U.S. Food and Drug Administration
Published: 2018-11-20

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K182288 for TPH Spectra ST Flowable Composite Restorative, Substantially Equivalent on 2018-11-20. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2018-08-23
Decision date: 2018-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Dentsply Sirona

view all

K262127 — DS Core CBCT Anatomy2026-08-21
K260785 — DS Core CBCT Anatomy2026-04-23
K253959 — Primevision 3D2026-02-05
K252343 — Atlantis® Abutments in Titanium2025-12-09
K252248 — CEREC Tessera Abutment System2025-11-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.