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510(k) Data Aggregation
K Number
K230797Device Name
SmartMTA Capsule
Manufacturer
Date Cleared
2023-03-24
(2 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Sprig Oral Health Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartMTA Capsule is indicated for use as:
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
- Pulpotomy/Partial Pulpotomy
Device Description
The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment. SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
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