Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813048658
• Version / Model: 9430209
• Catalog Number: 9430209
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-18
• Public Version: 1
• Public Version Date: 2022-07-26
• Public Version Status: New
• Public Device Record Key: b54e093f-428e-491a-a563-5c735d076bff

Device Description

TAKE HOME WHITENING KT12%HP(3)

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• 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
MAU	ERASER, DENTAL STAIN	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38785	Dental bleaching agent	A dental liquid solution or a paste used to whiten teeth for therapeutic or cosmetic purposes. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889813048658	GS1

Customer Contacts

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