Hexa

Basic Information

• Brand Name: Hexa
• Primary DI: 00850023750600
• Version / Model: HUB-005
• Company Name: Hexa Dental
• Labeler DUNS: 096955608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-05
• Public Version: 2
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: cf75637f-f325-4b20-8524-02dfce0515cf

Device Description

Hexa Universal Bonding 1-Step 5ml

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: 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
KLE	AGENT, TOOTH BONDING, RESIN	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850023750600	GS1
Package	10850023750607	GS1	box	88	In Commercial Distribution