Flight Dental Systems A6 Radius Package

GUDID D884A6EP1020

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

Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic

• Primary Device ID: D884A6EP1020
• NIH Device Record Key: da70db00-dfa9-432b-bcaa-106ee24991fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flight Dental Systems
• Version Model Number: A6EP-102
• Catalog Number: A6 Radius Package
• Company DUNS: 241275150
• Company Name: Flight Dental Systems
• 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	D884A6EP1020 [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: 2020-01-29
• Device Publish Date: 2020-01-21

On-Brand Devices [Flight Dental Systems]

• D884A6EP1020: A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff wi
• D884A6E0: A mains electricity (AC-powered) device designed to support a patient in a seated position to fa
• D884A12H0: A mains electricity (AC-powered) device designed to support a patient in a seated position to fa
• D884A6EP1000: A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff wi
• D884A12HP1000: The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system.
• D884XCURE0: This curing light is to provide photosensitive resins the activation required to cure the materi
• D884FMS25300: The Flight Magnetostrictive Ultrasonic Scaler is designed for use in prophylaxis treatments peri
• D884N6LED19020: Built in Piezo Scaler used for scaling teeth. Removing Carious material. Ultrasonic Scaler
• D884QC170: QC-170K
• D884F416: F-416BM
• D884F415: F-415BZ
• D884F160: F-160
• D884XR3800: The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lo
• D884QC6016K0: QC6016K
• D884QC4014K0: QC4014K
• D884LE15L00: LE15L
• D884LE1100: LE11
• D884LCH1100: LCH11
• D884HE22KL000: HE22KL
• D884HE21KL000: HE21KL
• D884HB23KL000: HB23KL
• D884HB23K000: hb23k
• D884AM0004: AM0004