visio.lign color, visio.lign shield— 510(k) K240735

Name: FDA 510(k) clearance K240735
Creator: U.S. Food and Drug Administration
Published: 2024-12-12

Substantially Equivalent

Bredent GmbH & Co. KG

FDA 510(k) clearance K240735 for visio.lign color, visio.lign shield, Substantially Equivalent on 2024-12-12. Applicant: Bredent GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Bredent GmbH & Co. KG
Product code: Code EBD
Device class: Class 2
Regulation: 21 CFR 872.3310
Advisory panel: Dental
Date received: 2024-03-18
Decision date: 2024-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Senden, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBD

view all

K254091 — GLOSSY COAT (15ML)2026-04-06
K250804 — ID LIGHT CURE SYSTEM2025-06-04
K223365 — RODIN Palette Naturalizing Kit2023-03-27
K211854 — VITA Akzent LC2021-11-22
K162408 — Nano Varnish, Plaquit, Lightpaint on Surface2018-04-05

More clearances from Bredent GmbH & Co. KG

view all

K152113 — BioHPP - breCAM.BioHPP2016-07-21
K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P2010-09-14

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