FDA 510(k)

Pekkton Ivory

K-Number: K170102 · 2017-11-13

Decision Date2017-11-13

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Pekkton Ivory is the device name listed in this FDA 510(k) record. The listed applicant is Cendres+Metaux SA. It received FDA 510(k) clearance on 2017-11-13 under 510(k) number K170102. 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 Pekkton Ivory?

Pekkton Ivory is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Cendres+Metaux SA. The 510(k) number is K170102.

When did Pekkton Ivory receive FDA 510(k) clearance?

Pekkton Ivory received FDA 510(k) clearance on 2017-11-13, under 510(k) number K170102.

Who is the listed applicant for Pekkton Ivory?

The FDA 510(k) record lists Cendres+Metaux SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pekkton Ivory?

The FDA product code for Pekkton Ivory is EBF.

Other records listing Cendres+Metaux SA 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.

K192251Livento Press, Soprano 10, Soprano

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K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group International K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International K260805Dual CoreVericom Co., Ltd.

Official Source

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