Vista-Cal Standard Kit

Basic Information

• Brand Name: Vista-Cal Standard Kit
• Primary DI: 10818207020205
• Version / Model: 502600
• Company Name: Vista Dental
• Labeler DUNS: 036623932
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 1
• Public Version Date: 2018-08-31
• Public Version Status: New
• Public Device Record Key: 4047995e-8827-400a-abde-8dccf9ba6db1

Device Description

12.5 pH aqueous solution for temporary filling and cleansing root canals. Standard kit includes (10) Visco-Tips™ & (4) 1.2mL prefilled high pressure syringes.

Device Characteristics

• Single Use: No
• 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: 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
KIF	Resin, Root Canal Filling	Dental	872.3820	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
Primary	10818207020205	GS1
Unit of Use	30818207020209	GS1

Premarket Submissions

Submission Number	Supplement Number
K963922	000