ENDOCEM MTA PREMIXED REGULAR

Primary DI
08800071200291
Brand
ENDOCEM MTA PREMIXED REGULAR
Company
MARUCHI
Model
ENDOCEM MTA PREMIXED REGULAR
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. It is designed to prevent irritation of pulp and secondary infections.ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal.The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage.
Published
2023-06-23
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
K213757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213757000Endocem MTA Premixed RegularMaruchi2023-02-14KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071200291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071200291088000712002918800071200291

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800071200017CleaniCalCleaniCal2023-05-16
08800071200093White ENDOSEAL MTAWhite ENDOSEAL MTA2023-06-23
D075B00AHBS10003G2AH Plus Bioceramic SealerSyringe Refill000932023-06-23
D075BKTAHBS0000001AH Plus Bioceramic SealerStarter Kit2023-06-23
08800071200000ENDOSEAL MTAENDOSEAL MTA2023-05-16
08800071200079ENDOCEM MTAENDOCEM MTA2023-05-16

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