AirLight M800

GUDID 00628504370827

M800-M/M4, M4 Backend, Triple Spray, Direct-LED

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00628504370827
• NIH Device Record Key: bf8c0f97-b684-436f-b63c-e7717cd2f0eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLight M800
• Version Model Number: HP3008
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada 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
GS1	00628504370827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112623

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00628504370827]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [AirLight M800]

• 00628504370827: M800-M/M4, M4 Backend, Triple Spray, Direct-LED
• 00628504370810: M800-M/ST, STAR Backend, Triple Spray, Direct-LED