PS System - Anterior Kit

Basic Information

• Brand Name: PS System - Anterior Kit
• Primary DI: 10818207024364
• Version / Model: 6000002
• Company Name: Vista Dental
• Labeler DUNS: 036623932
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: 520fbfc6-05ce-4d00-b116-daeaed0f98b4

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
NYL	Handpiece, Air-Powered, Root Canal Irrigation	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61428	Endodontic lavage system	An assembly of devices intended to enable lavage, through simultaneous irrigation and aspiration, of a prepared root canal to remove debris/bacteria. It is intended to be connected to the central vacuum line and includes appropriate vacuum line/syringe adaptor(s), tubing, and one or more suction cannulae (typically disposable). The suction cannulae are intended to draw irrigation solution to the apex of the root canal to flush the entire canal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10818207024364	GS1

Premarket Submissions

Submission Number	Supplement Number
K211721	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius