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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 the device name listed in this FDA 510(k) record. The listed applicant is Saremco Dental AG. It received FDA 510(k) clearance on 2024-06-27 under 510(k) 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. The listed applicant is Saremco Dental AG. The 510(k) number is K240823.

When did els extra low shrinkage® composite & els extra low shrinkage® flow receive FDA 510(k) clearance?

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

Who is the listed applicant for els extra low shrinkage® composite & els extra low shrinkage® flow?

The FDA 510(k) record lists Saremco Dental AG as the applicant. This does not by itself establish the device manufacturer.

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 records listing Saremco Dental AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252151els unibondK232050saremco print BRIDGETECK213343Saremco Print CROWNTEC

Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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.

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