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 a medical device manufactured by Cendres+Metaux SA. It received FDA 510(k) clearance on 2017-11-13 under approval 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. It is manufactured by Cendres+Metaux SA. The 510(k) number is K170102.

When was Pekkton Ivory approved by the FDA?

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

What company makes Pekkton Ivory?

Pekkton Ivory is manufactured by Cendres+Metaux SA.

What is the FDA product code for Pekkton Ivory?

The FDA product code for Pekkton Ivory is EBF.

Other Devices by Cendres+Metaux SA

K192251Livento Press, Soprano 10, Soprano

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.