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510(k) Data Aggregation
K Number
K231259Device Name
iRoot SP Plus
Manufacturer
Date Cleared
2023-05-31
(30 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Innovative BioCeramix, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Permanent obturation of the root canal following vital pulp-extirpation
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Device Description
iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.
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