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510(k) Data Aggregation
K Number
K132825Device Name
RETROMTA-ORTHOMTA II
Manufacturer
Date Cleared
2014-04-10
(213 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
BIOMTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RetroMTA-OrthoMTA II 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
Device Description
The major compositions of the RetroMTA-OrthoMTA II are dicalcium silicate, tricalcium silicate and tricalcium aluminate, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and is used in a putty form which gradually hardens in the oral environment. RetroMTA-OrthoMTA II is ideal for orthograde root canal filling. It 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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