White ENDOSEAL MTA

GUDID 08800071200093

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.

MARUCHI

Hygroscopic dental cement
Primary Device ID08800071200093
NIH Device Record Keye9f674a8-40a2-4911-a977-1da37ae739b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhite ENDOSEAL MTA
Version Model NumberWhite ENDOSEAL MTA
Company DUNS557821685
Company NameMARUCHI
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800071200093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

Devices Manufactured by MARUCHI

08800071200093 - White ENDOSEAL MTA2023-07-031. 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.
08800071200093 - White ENDOSEAL MTA2023-07-03 1. Description: White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require
08800071200291 - ENDOCEM MTA PREMIXED REGULAR2023-07-03 ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not requ
D075B00AHBS10003G2 - AH Plus Bioceramic Sealer2023-07-03 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not r
D075BKTAHBS0000001 - AH Plus Bioceramic Sealer2023-07-03 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not r
08800071200000 - ENDOSEAL MTA2023-05-24 1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. I
08800071200017 - CleaniCal2023-05-24 1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturat
08800071200079 - ENDOCEM MTA2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.