Harmonize
- Primary DI
- 00841396119613
- Brand
- Harmonize
- Company
- Kerr Corporation
- Model
- 36421
- Device description
- Nanohybrid Universal Composite Restorative; Syringe; Shade C3 Enamel
- Published
- 2017-05-04
- 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 |
|---|
| 10841396119610 | Package | GS1 | 1 | In Commercial Distribution |
| 00841396119613 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10841396119610 | 10841396119610 | | |
| 00841396119613 | 00841396119613 | 841396119613 | 0841396119613 |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store at ambient temperature |
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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00815967025856 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025863 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025870 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967021438 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967021797 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967027447 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028161 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028178 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028185 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028192 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028208 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028215 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 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 |
xxx.xxx