MARUCHI

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Endocem MTA Premixed Regular

  2023-02-14

  Maruchi

• White Endoseal MTA

  2021-08-13

  MARUCHI

• White ENDOSEAL MTA

  2021-03-24

  Maruchi

• CleaniCal

  2021-02-12

  Maruchi

• ENDOSEAL MTA

  2018-02-26

  MARUCHI

• ENDOCEM ZR

  2014-05-12

  MARUCHI

• ENDOSEAL

  2014-05-12

  MARUCHI

• ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

  2012-03-19

  MARUCHI

GUDID#

• CleaniCal - 1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturation and intracanal dressings of the root canal following removal of infected or necrotic pulp. It does not replace instrumentation / antibiotics to treat infected canals.2. Principle of operation: As a prefilled syringe product to quickly and easily dispense calcium hydroxide paste into the root canal, the CleaniCal consists of calcium hydroxide having disinfection effect. It is non-aqueous solvent to be easily dispensed in the root canal as a paste type product, and viscosity agent.3. Storage conditions: 1) The product must be stored at room temperature avoiding high temperature and humidity.2) The used 24 gauge tip shall be kept after its metal part cut off. A new 24 gauge tip must be used in next use.4. Shelf life: 2 years from date of manufacture.

  MARUCHI

  2023-05-16

• White ENDOSEAL MTA - 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

  2023-06-23

• ENDOCEM MTA PREMIXED REGULAR - 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.

  MARUCHI

  2023-06-23

• AH Plus Bioceramic Sealer - 1. Description: AH Plus Bioceramic Sealer 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: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer 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

  2023-06-23

• AH Plus Bioceramic Sealer - 1. Description: AH Plus Bioceramic Sealer 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: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer 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. 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

  2023-06-23

• ENDOSEAL MTA - 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.

  MARUCHI

  2023-05-16

• ENDOCEM MTA - 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

  2023-05-16