CHOICE 2 Starter Kit
- Primary DI
- D757C3900K1
- Brand
- CHOICE 2 Starter Kit
- Company
- BISCO INC.
- Model
- C-3900K
- Catalog number
- C-3900K
- Published
- 2017-06-12
- 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
- false
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 |
|---|
| D757C3900K1 | 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 20 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 053529939
- 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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| 00815967028321 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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| 00815967028345 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028352 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028369 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028376 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028383 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028390 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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