visio.lign color, visio.lign shield

FDA 510(k) K240735 · Bredent GmbH & Co. KG

Substantially Equivalent

510(k) numberK240735

Submission

Device name
visio.lign color, visio.lign shield
Applicant
Bredent GmbH & Co. KG
Senden, DE
Received
March 18, 2024
Decision date
December 12, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBD – Coating, Filling Material, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3310
Specialty
Dental

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Questions and answers

When was visio.lign color, visio.lign shield cleared by the FDA?

visio.lign color, visio.lign shield (K240735) received a 510(k) decision of Substantially Equivalent on December 12, 2024, 269 days after the submission was received.

What is the product code of K240735?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.