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Found 8 results
510(k) Data Aggregation
K Number
K213757Device Name
Endocem MTA Premixed Regular
Manufacturer
Maruchi
Date Cleared
2023-02-14
(441 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Maruchi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.
Device Description
ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.
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K Number
K212229Device Name
White Endoseal MTA
Manufacturer
MARUCHI
Date Cleared
2021-08-13
(28 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MARUCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent root canal obturation
Device Description
White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.
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K Number
K202015Device Name
White ENDOSEAL MTA
Manufacturer
Maruchi
Date Cleared
2021-03-24
(246 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Maruchi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent root canal obturation
Device Description
This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.
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K Number
K201799Device Name
CleaniCal
Manufacturer
Maruchi
Date Cleared
2021-02-12
(227 days)
Product Code
EJK, KIF
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
Maruchi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:
* Temporary disinfectant dressings in the obturation of root canals;
* Indirect pulp capping or management of deep caries lesions; or
* Direct pulp capping.
Device Description
CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.
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K Number
K170175Device Name
ENDOSEAL MTA
Manufacturer
MARUCHI
Date Cleared
2018-02-26
(403 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MARUCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.
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K Number
K133042Device Name
ENDOCEM ZR
Manufacturer
MARUCHI
Date Cleared
2014-05-12
(227 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MARUCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A root-end filling material
- For the repair of root canals as an apical plug during apexification
- For repair of root perforations during root canal therapy
- As a consequence of internal resorption
- As a pulp capping material
- For the filling of pulpotomy of deciduous tooth
Device Description
The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, 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.
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K Number
K133054Device Name
ENDOSEAL
Manufacturer
MARUCHI
Date Cleared
2014-05-12
(227 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MARUCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- . Repair of perforation
- . Root canal filling
Device Description
The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.
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K Number
K112078Device Name
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
Manufacturer
MARUCHI
Date Cleared
2012-03-19
(242 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MARUCHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A root-end filling material
- For the repair of root canals as an apical plug during apexification
- For repair of root perforations during root canal therapy
- As a consequence of internal resorption
- As a pulp capping material
- For the filling of pulpotomy of deciduous tooth
Device Description
This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.
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