Darby Dental Supply, LLC

Basic Information

• Brand Name: Darby Dental Supply, LLC
• Primary DI: 00889813017289
• Version / Model: 9510946
• Catalog Number: 9510946
• Company Name: DARBY DENTAL SUPPLY, LLC
• Labeler DUNS: 825137818
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-05-04
• Public Version: 1
• Public Version Date: 2018-06-04
• Public Version Status: New
• Public Device Record Key: b40a7c33-9423-4492-97bd-85a57ed9fb47

Device Description

Plastic Thermal Obturator .08 #20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKM	GUTTA-PERCHA	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47750	Warm-bonded endodontic obturation system	An assembly of devices designed to deliver preheated resin-based sealing, filling, and core materials into a root canal for direct warm bonding during an endodontic obturation procedure. It typically consists of a mains electricity (AC-powered) oven used to heat the preloaded oburators, a series of root canal sizers (verifiers) used for the selection of the appropriate obturator, and preloaded obturators; other materials may be included (e.g., self-etch sealer).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889813017289	GS1
Unit of Use	00889813017272	GS1

Customer Contacts

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