SCOTT'S BIG-BITE HP 2/bx SUPER-FAST SET BERRY

Basic Information

• Brand Name: SCOTT'S BIG-BITE HP 2/bx SUPER-FAST SET BERRY
• Primary DI: D77810471121
• Version / Model: 104-7112
• Catalog Number: 104-7112
• 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: 1ab578f3-90e1-4747-ba86-f3674abd74d8

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, super-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	D77810471121	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 73 Degrees Fahrenheit