FDA 510(k)

Any-Com Bulk

K-Number: K242713 · 2025-02-07

Decision Date2025-02-07

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Any-Com Bulk is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-02-07 under approval number K242713. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Any-Com Bulk?

Any-Com Bulk is a medical device that received FDA 510(k) clearance on 2025-02-07. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K242713.

When was Any-Com Bulk approved by the FDA?

Any-Com Bulk received FDA 510(k) clearance on 2025-02-07, under approval number K242713.

What company makes Any-Com Bulk?

Any-Com Bulk is manufactured by Mediclus Co., Ltd..

What is the FDA product code for Any-Com Bulk?

The FDA product code for Any-Com Bulk is EBF.

Other Devices by Mediclus Co., Ltd.

K230465Hi-Bond Universal K241147Any-Com K232182One-Fil K252465Any-Core K251884One-Fil Putty Injectable K251283Once-Fil Flow

View all 13 devices →

Related Devices (Code: EBF)

K163207Filtek One Bulk Fill Restorative3M Company K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group) K162257P1145 Dental RestorativeKerr Corporation K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.