Beautifil II

Basic Information

• Brand Name: Beautifil II
• Primary DI: E235BIIK10
• Version / Model: 001
• Catalog Number: BIIK1
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 2
• Public Version Date: 2022-08-04
• Public Version Status: Update
• Public Device Record Key: 1b090365-c535-4db0-9101-22087cc06f5a
• Distribution End Date: 2022-08-03

Device Description

Beautifil II Refill Tips Shade A2 BurButler Kit . Contains DI: E23517530

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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
35861	Gingival retraction cord, non-medicated	A non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E235BIIK10	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius