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 Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic 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