DEVICE: VacStar (D678560420)
Device Identifier (DI) Information
VacStar
56042
In Commercial Distribution
AIR TECHNIQUES, INC.
56042
In Commercial Distribution
AIR TECHNIQUES, INC.
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
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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NRD | Unit, Operative Dental, Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4e8bdcf1-099c-41d0-8078-8f6697128f82
January 27, 2023
1
January 19, 2023
January 27, 2023
1
January 19, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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D678560421 | 1 | D678560420 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (516) 214-5512
mardonio.nicolas@airtechniques.com
mardonio.nicolas@airtechniques.com