Radica®

Basic Information

• Brand Name: Radica®
• Primary DI: D0019081080
• Version / Model: Dentin D2
• Catalog Number: 908108
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2022-05-16
• Public Version Status: Update
• Public Device Record Key: ed71c402-e189-4dcb-a2ed-24218f0b4a48
• Distribution End Date: 2022-05-13

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
EBD	COATING, FILLING MATERIAL, RESIN	Dental	872.3310	2
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D0019083401	HIBCC		12	Not in Commercial Distribution	2022-05-12
Primary	D0019081080	HIBCC

Customer Contacts

• Phone: [phone] ext. 54660
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	5	Gram