ENDOCEM MTA

GUDID 08800071200079

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.

MARUCHI

Hygroscopic dental cement
Primary Device ID08800071200079
NIH Device Record Key5e2110e2-f4e8-4445-9b04-d9ca362a3687
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOCEM MTA
Version Model NumberENDOCEM 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800071200079 [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 Date2023-05-24
Device Publish Date2023-05-16

Devices Manufactured by MARUCHI

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 MTA2023-05-241. 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.
08800071200079 - ENDOCEM MTA2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr

Trademark Results [ENDOCEM MTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOCEM MTA
ENDOCEM MTA
79124101 4582159 Live/Registered
MARUCHI
2012-12-07

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