CleaniCal
GUDID 08800071200017
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
Endodontic temporary cement| Primary Device ID | 08800071200017 |
| NIH Device Record Key | 2ef4a0a0-3a51-4d6a-b4ee-a639e1c7b619 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CleaniCal |
| Version Model Number | CleaniCal |
| Company DUNS | 557821685 |
| Company Name | MARUCHI |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800071200017 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201799
FDA Product Code
| KIF | Resin, Root Canal Filling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-24 |
| Device Publish Date | 2023-05-16 |
Devices Manufactured by MARUCHI
| 08800071200093 - White ENDOSEAL MTA | 2023-07-03 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 REGULAR | 2023-07-03 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 Sealer | 2023-07-03 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 Sealer | 2023-07-03 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 MTA | 2023-05-24 1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. I |
| 08800071200017 - CleaniCal | 2023-05-241. 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. |
| 08800071200017 - CleaniCal | 2023-05-24 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 MTA | 2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr |
Trademark Results [CleaniCal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEANICAL 90650268 not registered Live/Pending |
Ronert Health, LLC 2021-04-16 |
 CLEANICAL 88090815 not registered Live/Pending |
Stella & Dot LLC 2018-08-23 |
 CLEANICAL 87532083 5722978 Live/Registered |
MARUCHI 2017-07-18 |
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