AirLight M800P

GUDID 00628504370773

M800P-S/PD, Beyes PD Backend, Standard Head, Triple Spray, Direct-LED

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00628504370773
• NIH Device Record Key: aafef5d2-d1cd-48da-a161-b68d5461da6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLight M800P
• Version Model Number: HP6028P
• 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	00628504370773 [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

[00628504370773]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-22
• Device Publish Date: 2019-04-13

On-Brand Devices [AirLight M800P]

• 00628504370803: M800P-S/K, KaVo Backend, Standard Head, Triple Spray, Direct-LED
• 00628504370797: M800P-S/W, W&H Backend, Standard Head, Triple Spray, Direct-LED
• 00628504370780: M800P-S/N, NSK Backend, Standard Head, Triple Spray, Direct-LED
• 00628504370773: M800P-S/PD, Beyes PD Backend, Standard Head, Triple Spray, Direct-LED
• 00628504370766: M800P-S/QD, Beyes QD Backend, Standard Head, Triple Spray, Direct-LED
• 00628504370322: M800P-M/PD, Beyes PD Backend, Triple Spray, Direct-LED
• 00628504370278: M800P-M/ST, STAR Backend, Triple Spray, Direct-LED
• 00628504370230: M800P-M/N, NSK Backend, Triple Spray, Direct-LED
• 00628504370209: M800P-M/K, KaVo Backend, Triple Spray, Direct-LED
• 00628504370193: M800P-M/W, W&H Backend, Triple Spray, Direct-LED
• 00628504370162: M800P-M/M4, M4 Backend, Triple Spray, Direct-LED