VacStar

Basic Information

• Brand Name: VacStar
• Primary DI: D678K11500
• Version / Model: K1150
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-20
• Public Version: 1
• Public Version Date: 2023-01-30
• Public Version Status: New
• Public Device Record Key: 0b48ec76-47b0-425d-8444-8281d1fa9e61

Device Description

The VacStar family creates vacuum that will be used in a dental facility. The VacStar system is designed for reliable operation in the modern dental facility. The system is a water ring vacuum pump used to produce the high-volume air flow required for multiple simultaneous users. The gases are vented out and the liquid and its particulates are directed down the drain. The clean water extracted during this separation process is directed back toward the VacStar where it is mixed with fresh water and then directed into the pump chamber to create vacuum. This efficient reuse of water reduces the VacStar's fresh water consumption. If the optional HydroMiser is used, water consumption can be reduced by up to 75%. In addition, VacStar NEO incorporates an efficient energy management system. This is accomplished by adding a Variable Frequency Drive (VFD) to the Vacuum Pump. This VFD adjusts the frequency of the pump to maintain the required vacuum level depending on the demand. With this balanced system, users are provided with the necessary the flow rate while conserving electricity and prolonging the life of the pump.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D678K11501	HIBCC	Box	1	In Commercial Distribution
Primary	D678K11500	HIBCC

Customer Contacts

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