CLEARFIL™ SE BOND Restorative Kit
- Primary DI
- EKUR001985KA1
- Brand
- CLEARFIL™ SE BOND Restorative Kit
- Company
- KURARAY NORITAKE DENTAL INC.
- Model
- #1985-KA
- Published
- 2017-02-17
- Public version status
- Update
- 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 |
|---|
| EKUR001985KA1 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 697119498
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- 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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