DuraMax

GUDID 00628504370841

M800-M/PD/NS,SMART,Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00628504370841
• NIH Device Record Key: 11dff333-61ab-46b6-9f95-02665b61ac56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraMax
• Version Model Number: HP3057
• 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	00628504370841 [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

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

[00628504370841]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

On-Brand Devices [DuraMax ]

• 00628504370841: M800-M/PD/NS,SMART,Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED
• 00628504370834: M800-M/PD/NS PLUS Beyes PD Backend, Single Stream, Safeguard Air Technology, Direct-LED