SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY
Basic Information
- Brand Name
- SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY
- Primary DI
- D77810471101
- Version / Model
- 104-7110
- Catalog Number
- 104-7110
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-25
- Public Version
- 3
- Public Version Date
- 2020-08-26
- Public Version Status
- Update
- Public Device Record Key
- a50804a6-91e3-4eaa-9777-c94bbc8fb34a
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D77810471101 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 73 Degrees Fahrenheit