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FDA 510(k)

iRoot SP Plus

K-Number: K231259 · 2023-05-31

ApplicantInnovative Bioceramix, Inc.
Decision Date2023-05-31
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iRoot SP Plus is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) 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. The listed applicant is Innovative Bioceramix, Inc.. The 510(k) number is K231259.

When did iRoot SP Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for iRoot SP Plus?

The FDA 510(k) record lists Innovative Bioceramix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iRoot SP Plus?

The FDA product code for iRoot SP Plus is KIF.

Other records listing Innovative Bioceramix, Inc. 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.

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

Related Devices (Code: KIF)

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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus 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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