MARK3
- Primary DI
- D79659780
- Brand
- MARK3
- Company
- CARGUS INTERNATIONAL, INC
- Model
- 5978
- Device description
- Canal Prep Root Canal Preparation Cream 18gm. - MARK3
- Published
- 2021-07-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KJJ | Cleanser, Root Canal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KJJ | Cleanser, Root Canal | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D79659780 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Root canal cleaning solution | A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 096191093
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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