Medidenta Air Free 45

GUDID D884AF450

Air Free 45 Degree Handpiece

Flight Dental Systems

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• Primary Device ID: D884AF450
• NIH Device Record Key: 5cf0af75-5630-4469-ae89-2e4c38c7eee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medidenta Air Free 45
• Version Model Number: AF45
• 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	D884AF450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181691

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

[D884AF450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-18
• Device Publish Date: 2021-02-10

Devices Manufactured by Flight Dental Systems

• D884AM0004 - Flight Dental Systems: 2022-02-04
• D884HB23K000 - Flight Dental Systems: 2022-02-04
• D884HB23KL000 - Flight Dental Systems: 2022-02-04
• D884HE21KL000 - Flight Dental Systems: 2022-02-04
• D884HE22KL000 - Flight Dental Systems: 2022-02-04
• D884LCH1100 - Flight Dental Systems: 2022-02-04
• D884LE1100 - Flight Dental Systems: 2022-02-04
• D884LE15L00 - Flight Dental Systems: 2022-02-04