Identity
- Trade Name
- SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 104-7110 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 104-7110 FDA UDI
- Primary DI / UDI-DI
- D77810471101 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDI
Category: Silicone dental impression material
SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY by Scott's Dental Supply L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI a50804a6-91e3-4eaa-9777-c94bbc8fb34a 37 fields · synced May 30, 2026