Velvet Etch

Basic Information

• Brand Name: Velvet Etch
• Primary DI: 10818207020878
• Version / Model: 503315
• Company Name: Vista Dental
• Labeler DUNS: 036623932
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-13
• Public Version: 1
• Public Version Date: 2021-05-21
• Public Version Status: New
• Public Device Record Key: fe5ccc99-eb4b-4ebb-a93f-075270850619

Device Description

4x1.2ml Syringe 40% Phosphoric Acid Etch Gel

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: No
• 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
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20818207020875	GS1		20	In Commercial Distribution
Primary	10818207020878	GS1
Direct Marking	00818207020871	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius