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510(k) Data Aggregation
K Number
K161239Device Name
MTA2.2 MATERIAL
Manufacturer
AVALON BIOMED INC.
Date Cleared
2016-09-01
(122 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
AVALON BIOMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTA2.2 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
Device Description
The MTA2.2 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material 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) in primary or secondary teeth.
The dentist will mix the powder and water-based gel of MTA2.2 and place the mixed MTA2.2 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.2 MATERIAL is tinted yellow, pink and gray.
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K Number
K140955Device Name
MTA2.1 MATERIAL
Manufacturer
AVALON BIOMED INC.
Date Cleared
2014-06-11
(58 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
AVALON BIOMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTA2.1 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
Device Description
The MTA2.1 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material 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) in primary or secondary teeth. The dentist will mix the powder and water-based gel and place the mixed MTA2.1 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.1 MATERIAL is tinted yellow, pink and gray.
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K Number
K122892Device Name
MTA2 ROOT AND PULP MATERIALS
Manufacturer
AVALON BIOMED INC.
Date Cleared
2012-12-11
(82 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
AVALON BIOMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
Device Description
The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in dental procedures that contact with vital pulp tissue and periradicular tissue, as well as obturation and sealing of root canals. The MTA2 ROOT AND PULP MATERIALS can be used for dental procedures such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and sealing/obturation. The dentist mixes the powder with the provided gel and places the mixed MTA2 material into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. The MTA2 ROOT AND PULP MATERIALS are available in white or gray.
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