White ENDOSEAL MTA

Primary DI
08800071200093
Brand
White ENDOSEAL MTA
Company
MARUCHI
Model
White ENDOSEAL MTA
Device description
1. 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.2. Principle of operation: White ENDOSEAL MTA is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. White ENDOSEAL MTA seals between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties.3. Storage conditions: 1) The product must be stored at room temperature (15 - 25°C) avoiding high temperature and humidity.2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities.3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head.4) Place the syringe into the foil pouch and ensure to seal the pouch.4. Shelf life: 2 years from date of manufacture.
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
K212229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212229000White Endoseal MTAMaruchi2021-08-13KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071200093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071200093088000712000938800071200093

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
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
08800071200079ENDOCEM MTAENDOCEM MTA2023-05-16

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