SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY
- Primary DI
- D77810471101
- Brand
- SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY
- Company
- SCOTT'S DENTAL SUPPLY L.L.C.
- Model
- 104-7110
- Catalog number
- 104-7110
- Device description
- Big-Bite Bite Registration material is a unique mousse-like, radiopaque impression material that was designed for registering bite relationships between upper and lower jaws. The thixotropic properties of this material allow for easy flow without slumping. The material’s high durometer helps ensure accurate model articulation. Big-Bite Bite Registration material is compatible with gypsum or epoxy die materials and can be copper or silver plated. Big-Bite Bite Registration material is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. Delivery Method: Dispensing Cartridge, fast set, berry flavor. SDS and instructions for use available at https://www.scottsdental.com/big-bite-registration-hp.html
- Published
- 2018-10-25
- 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 |
|---|
| ELW | Material, Impression |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELW | Material, Impression | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D77810471101 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 50 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 | 73 Degrees Fahrenheit | |
| Storage Environment Temperature | 0 Degrees Fahrenheit | 73 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 137217043
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- 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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