Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813001851
• Version / Model: 9430108
• Catalog Number: 9430108
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 3
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 69bab5b9-cbe5-4fa4-b79c-77a27b6c5090

Device Description

Temporary Crown & Bridge 10:1 50ml Cartridge B1

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889813001851	GS1

Customer Contacts

• Phone: [phone] ext. 6431
• Email: [email protected]