Flight Dental Systems

GUDID D178A6EP1000

A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Flight Dental Systems USA Inc.

Dental delivery system instrument unit, pneumatic

• Primary Device ID: D178A6EP1000
• NIH Device Record Key: d0044198-e1eb-43a2-bd18-ca1bc462266f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flight Dental Systems
• Version Model Number: A6EP-100
• Company DUNS: 119439759
• Company Name: Flight Dental Systems USA Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D178A6EP1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070196

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-29

On-Brand Devices [Flight Dental Systems]

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• D178CLAVE45: Clave45+ Steam Sterilizer – Large Capacity with Class B Upgradability The Clave45+ from Flight
• D178CLAVE28: The Clave28+ from Flight Dental Systems is a high-capacity Class S steam sterilizer designed to
• D178CLAVE23: Clave23+ Autoclave – High Capacity, Class S Sterilization Excellence The Clave23+ Autoclave fr
• D178CLAVE16: Clave16+ Autoclave – Reliable, Compact, and Efficient Sterilization The Clave16+ Autoclave fro
• D178XR3800: The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lo
• D178QC170: QC-170K
• D178QC165K1: QC-165K
• D178QC164K1: QC-164K
• D178N6LED19020: D548627
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• D178F160: F-160
• D178BI22530K1: Flight Magnetostrictive Ultrasonic Built in Scaler
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• D178A6EP1000: A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff wi
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• D178A12HP1000: The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system.
• D178A12H0: A mains electricity (AC-powered) device designed to support a patient in a seated position to fa