Hexa

Basic Information

• Brand Name: Hexa
• Primary DI: 10850023750751
• Version / Model: CU-2009
• Catalog Number: CU-2009
• Company Name: Hexa Dental
• Labeler DUNS: 096955608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2023-03-28
• Public Version: 3
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: c9b2a6e6-47ce-4346-861c-ad218c852d89

Device Description

Hexa Composite Enamel BLEACH, Caplets (20)

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: 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
EBF	Material, tooth shade, resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62477	Dental composite resin kit	A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. 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	10850023750751	GS1
Unit of Use	00850023750754	GS1
Package	20850023750758	GS1	box	64	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]