Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

els extra low shrinkage® composite & els extra low shrinkage® flow

K-Number: K240823 · 2024-06-27

ApplicantSaremco Dental AG
Decision Date2024-06-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

els extra low shrinkage® composite & els extra low shrinkage® flow is a medical device manufactured by Saremco Dental AG. It received FDA 510(k) clearance on 2024-06-27 under approval number K240823. 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 els extra low shrinkage® composite & els extra low shrinkage® flow?

els extra low shrinkage® composite & els extra low shrinkage® flow is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Saremco Dental AG. The 510(k) number is K240823.

When was els extra low shrinkage® composite & els extra low shrinkage® flow approved by the FDA?

els extra low shrinkage® composite & els extra low shrinkage® flow received FDA 510(k) clearance on 2024-06-27, under approval number K240823.

What company makes els extra low shrinkage® composite & els extra low shrinkage® flow?

els extra low shrinkage® composite & els extra low shrinkage® flow is manufactured by Saremco Dental AG.

What is the FDA product code for els extra low shrinkage® composite & els extra low shrinkage® flow?

The FDA product code for els extra low shrinkage® composite & els extra low shrinkage® flow is EBF.

Other Devices by Saremco Dental AG

K213343Saremco Print CROWNTEC K232050saremco print BRIDGETEC K252151els unibond

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.

↑