KATANA AVENCIA Block
- Primary DI
- EKUR004101KA1
- Brand
- KATANA AVENCIA Block
- Company
- KURARAY NORITAKE DENTAL INC.
- Model
- #4101-KA
- Device description
- 12/A2 LT (CEREC)
- Published
- 2019-04-30
- 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
- true
Product Codes
| Code | Name |
|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EKUR004101KA1 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental crown, polymer | A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. |
Regulatory Flags
- DUNS number
- 697119498
- 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
- false
- 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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