DenMat Bulk Fill Composite— 510(k) K242097

Name: FDA 510(k) clearance K242097
Creator: U.S. Food and Drug Administration
Published: 2024-10-15

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K242097 for DenMat Bulk Fill Composite, Substantially Equivalent on 2024-10-15. Applicant: Den-Mat Holdings, LLC. Device class: 2.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2024-07-18
Decision date: 2024-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lompoc, CA, 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 Den-Mat Holdings, LLC

view all

K162967 — nuance UNIVERSAL2017-03-24
K143679 — Nuance FLOW2015-05-01
K140537 — TENURE4G2014-08-20
K110079 — SPPHINE PLUS STM 3W DIODE LASER2011-02-10
K103667 — SAPPHIRE ST PORTABLE DIODE LASER2010-12-29

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