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510(k) Data Aggregation
K Number
K181917Device Name
MTA2.3 MATERIALS
Manufacturer
NuSmile, LTD.
Date Cleared
2019-01-11
(178 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
NuSmile, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTA2.3 ROOT & PULP MATERIALS are indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
Device Description
The MTA2.3 ROOT & PULP MATERIALS are designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. The materials can be used for dental procedures contacting pulpal or periradicular tissue such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and obturation (pulpectomy) including root canal sealing.
MTA2.3 ROOT & PULP MATERIALS were developed in 2 forms (designs): powder with water-based gel, and pastes. The dentist may choose to mix the powder and water-based gel of MTA2.3 (design 1), or choose to use a paste form of MTA2.3 (design 2). The MTA2.3 ROOT & PULP MATERIALS are placed in the space created by the procedure and set in vivo. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. Such procedures are performed on primary and secondary dentition. MTA2.3 ROOT & PULP MATERIALS may be white or tinted yellow, pink or gray. MTA2.3 ROOT & PULP MATERIALS are color stable over time.
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