Transcend Bulk Fill Flowable Composite— 510(k) K262228

Name: FDA 510(k) clearance K262228
Creator: U.S. Food and Drug Administration
Published: 2026-07-01

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K262228 for Transcend Bulk Fill Flowable Composite, Substantially Equivalent on 2026-07-01. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2026-06-30
Decision date: 2026-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K261246 — SRGC-062026-06-18
K261093 — DIAFIL2026-06-02
K261071 — DIAFIL Bulk FLOW (3 models)2026-05-19
K260805 — Dual Core2026-05-11

More clearances from Ultradent Products, Inc.

view all

K261404 — UltraEZ2026-04-30
K240743 — Peak Universal Bond2024-03-20
K240694 — FORMA Composite (Shade A3D)2024-03-15
K221909 — J-Temp2022-07-01
K220471 — VALO X, VALO X Accessory Lenses2022-02-22

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