MAKR3
- Primary DI
- D79648821
- Brand
- MAKR3
- Company
- CARGUS INTERNATIONAL, INC
- Model
- 4882
- Device description
- Hybrid Composite A2 Unidose .25gm. 20/pk. - MARK3
- Published
- 2017-04-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|
| D79648821 | Primary | HIBCC | 0 | |
| D7964882 | Unit of Use | HIBCC | 0 | |
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 |
|---|
| Storage Environment Temperature | 0 Degrees Fahrenheit | 74 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 096191093
- Device count
- 20
- 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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| 00815967028260 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028277 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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| 00815967028291 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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| 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 |
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| 00815967028383 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028390 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |