FDA 510(k)

Vittra APS Unique

K-Number: K210231 · 2021-10-14

Decision Date2021-10-14

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Vittra APS Unique is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2021-10-14 under approval number K210231. 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 Vittra APS Unique?

Vittra APS Unique is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Dentscare Ltda. The 510(k) number is K210231.

When was Vittra APS Unique approved by the FDA?

Vittra APS Unique received FDA 510(k) clearance on 2021-10-14, under approval number K210231.

What company makes Vittra APS Unique?

Vittra APS Unique is manufactured by Dentscare Ltda.

What is the FDA product code for Vittra APS Unique?

The FDA product code for Vittra APS Unique is EBF.

Other Devices by Dentscare Ltda

K191306Llis, Vittra APS K183424Ambar, Ambar APS, Ambar Universal APS K183465Allcem, Allcem Core K190758Opus Bulk Fill APS, Opus Bulk Fill Flow APS K201707Opallis, Opallis Flow K192682Orthocem, Ortho Bite

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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.