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FDA 510(k)

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

K-Number: K222992 · 2022-11-22

ApplicantInnovative Bioceramix, Inc.
Decision Date2022-11-22
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is a medical device manufactured by Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2022-11-22 under approval number K222992. 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 BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Innovative Bioceramix, Inc.. The 510(k) number is K222992.

When was iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material approved by the FDA?

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material received FDA 510(k) clearance on 2022-11-22, under approval number K222992.

What company makes iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is manufactured by Innovative Bioceramix, Inc..

What is the FDA product code for iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material?

The FDA product code for iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material is KIF.

Related Clinical Trials

NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING NCT06710795 AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair ACTIVE_NOT_RECRUITING NCT07388901 In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers RECRUITING

Related PubMed Literature

PMID: 40876809 Applications of Tissue-Inducing Biomaterials in Nonosseous Tissues: Evidence Map of Animal Studies. Tissue engineering. Part A (2026)

Other Devices by Innovative Bioceramix, Inc.

K231259iRoot SP Plus

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom 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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