FDA 510(k)

iRoot SP Plus

K-Number: K231259 · 2023-05-31

Decision Date2023-05-31

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

iRoot SP Plus is a medical device manufactured by Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2023-05-31 under approval number K231259. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iRoot SP Plus?

iRoot SP Plus is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Innovative Bioceramix, Inc.. The 510(k) number is K231259.

When was iRoot SP Plus approved by the FDA?

iRoot SP Plus received FDA 510(k) clearance on 2023-05-31, under approval number K231259.

What company makes iRoot SP Plus?

iRoot SP Plus is manufactured by Innovative Bioceramix, Inc..

What is the FDA product code for iRoot SP Plus?

The FDA product code for iRoot SP Plus is KIF.

Other Devices by Innovative Bioceramix, Inc.

K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material

Related Devices (Code: KIF)

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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.