TEMP TABS TRUE BLUE
- Primary DI
- D8161430200
- Brand
- TEMP TABS TRUE BLUE
- Company
- ALL DENTAL PRODX
- Model
- 143020
- Device description
- A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
- Published
- 2016-09-20
- 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 |
|---|
| EBG | Crown And Bridge, Temporary, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D8161430200 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Composite dental impression material | A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Fahrenheit | 145 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 002287223
- Device count
- 1
- DM exempt
- true
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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