ENDOCEM MTA

Primary DI
08800071200079
Brand
ENDOCEM MTA
Company
MARUCHI
Model
ENDOCEM MTA
Device description
1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary infections. It is a powder type. Use with saline or distilled water. The mixing ratio is 300 mg / 0.12 cc.2. Principle of operation: ENDOCEM MTA is natural pure cement based endodontic material. product based on the science of pozzolan reactions. It has a fast setting time that allows for resin bonding to occur immediately after setting. It maintains its integrity in less than ideal clinical situations, including contamination with blood or saliva and presence of inflammation or infection.3. Storage conditions: 1) The product shall be kept out of direct sunlight and stored at room temperature. It shall not be stored in a place with high temperature and humidity.2) The remaining material shall be disposed of. 4. Shelf life: 3 years from manufacture date if storage conditions are followed.
Published
2023-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112078000ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)Maruchi2012-03-19KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071200079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071200079088000712000798800071200079

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557821685
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800071200017CleaniCalCleaniCal2023-05-16
08800071200093White ENDOSEAL MTAWhite ENDOSEAL MTA2023-06-23
08800071200291ENDOCEM MTA PREMIXED REGULARENDOCEM MTA PREMIXED REGULAR2023-06-23
D075B00AHBS10003G2AH Plus Bioceramic SealerSyringe Refill000932023-06-23
D075BKTAHBS0000001AH Plus Bioceramic SealerStarter Kit2023-06-23
08800071200000ENDOSEAL MTAENDOSEAL MTA2023-05-16

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