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FDA 510(k)

3Delta Crown

K-Number: K211804 · 2021-12-06

ApplicantDeltamed GmbH
Decision Date2021-12-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Delta Crown is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2021-12-06 under 510(k) number K211804. 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 3Delta Crown?

3Delta Crown is a medical device that received FDA 510(k) clearance on 2021-12-06. The listed applicant is Deltamed GmbH. The 510(k) number is K211804.

When did 3Delta Crown receive FDA 510(k) clearance?

3Delta Crown received FDA 510(k) clearance on 2021-12-06, under 510(k) number K211804.

Who is the listed applicant for 3Delta Crown?

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

What is the FDA product code for 3Delta Crown?

The FDA product code for 3Delta Crown is EBF.

Other records listing Deltamed GmbH 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.

K2437203Delta UNlimitedK230341ACRIFIXK2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixK200039P pro Crown & Bridge

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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