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FDA 510(k)

Saremco Print CROWNTEC

K-Number: K213343 · 2022-01-21

ApplicantSaremco Dental AG
Decision Date2022-01-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Saremco Print CROWNTEC 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 2022-01-21 under 510(k) number K213343. 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 Saremco Print CROWNTEC?

Saremco Print CROWNTEC is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Saremco Dental AG. The 510(k) number is K213343.

When did Saremco Print CROWNTEC receive FDA 510(k) clearance?

Saremco Print CROWNTEC received FDA 510(k) clearance on 2022-01-21, under 510(k) number K213343.

Who is the listed applicant for Saremco Print CROWNTEC?

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 Saremco Print CROWNTEC?

The FDA product code for Saremco Print CROWNTEC 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 unibondK240823els extra low shrinkage® composite & els extra low shrinkage® flowK232050saremco print BRIDGETEC

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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