ENDOSEAL MTA

Primary DI
08800071200000
Brand
ENDOSEAL MTA
Company
MARUCHI
Model
ENDOSEAL MTA
Device description
1. 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. It is eugenol-free and will not impede adhesion inside the root canal.2. Principle of operation: The essential principle of operation is that calcium silicate, an ingredient of natural cement in the Endoseal MTA, quickly conducts hydration reactions by absorbing moisture around the mouth and root canals due to hygroscopic materials, and starts to harden.3. Storage conditions: 1) The product should be stored at room temperature avoiding high temperature and humidity.2) The product use immediately after replacing the 24 gauge tip because it will be hardened when in contact with air. 3) After using the 24 gauge tip, keep the metal part cut off. A new 24 gauge tip replaces it in next use. 4. Shelf life: 2 years from date of manufacture.
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
K170175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170175000ENDOSEAL MTAMaruchi2018-02-26KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071200000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071200000088000712000008800071200000

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
08800071200079ENDOCEM MTAENDOCEM MTA2023-05-16

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