CleaniCal

Primary DI
08800071200017
Brand
CleaniCal
Company
MARUCHI
Model
CleaniCal
Device description
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.
Published
2023-05-16
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
EJKLiner, Cavity, Calcium Hydroxide
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201799000CleaniCalMaruchi2021-02-12EJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071200017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071200017088000712000178800071200017

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic temporary cementA viscous material intended to be applied to a prepared root canal to maintain its relative sterility between procedures and to facilitate its healing. It is intended to be placed within the root canal temporarily and sealed with a temporary filling material to prevent repopulation of the canal by bacteria. It is typically a zinc or calcium cement-based material that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a tube or syringe. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 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

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08800071200079ENDOCEM MTAENDOCEM MTA2023-05-16

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