CleaniCal
Basic Information
- Brand Name
- CleaniCal
- Primary DI
- 08800071200017
- Version / Model
- CleaniCal
- Company Name
- MARUCHI
- Labeler DUNS
- 557821685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 1
- Public Version Date
- 2023-05-24
- Public Version Status
- New
- Public Device Record Key
- 2ef4a0a0-3a51-4d6a-b4ee-a639e1c7b619
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60275 | Endodontic temporary cement | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800071200017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201799 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius