Build-It FR
- Primary DI
- 00814978021185
- Brand
- Build-It FR
- Company
- Kerr Corporation
- Model
- N32AA
- Device description
- Core Material; Cartridge; A2
- Published
- 2016-08-01
- 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 |
|---|
| 00814978021185 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00814978021185 | 00814978021185 | 814978021185 | 0814978021185 |
GMDN Terms
| Term | Definition |
|---|
| Self-cured dental restorative composite resin | A dental restorative material consisting of a blend of glass or ceramic particles dispersed in a synthetic, self-polymerizable, organic resin matrix that is typically used to fill dental cavities or restore damaged dental tissue. It is typically a two-paste system (self-cured when put together) consisting basically of a dimethacrylate resin [(e.g., a bisphenol A and glycidylmethacrylate (BIS-GMA)]; the filler is usually made of glass, quartz, or ceramic. Typically, one paste contains an accelerator and the other a catalyst which polymerize a solid resin. This single-use product should match the colour of the original teeth for aesthetic reasons. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 25 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 199354556
- 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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| 00815967028222 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028239 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028246 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028253 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028260 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028277 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028284 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028291 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028307 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028314 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028321 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028338 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 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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