EZ-Swivel EZ-Swivel N E6

GUDID 00990010306455

EZ-Swivel N E6, Coupler E6, 6 Holes, Optic

Beyes Dental Canada Inc

Pneumatic dental handpiece coupler

• Primary Device ID: 00990010306455
• NIH Device Record Key: 4b277a16-e6cf-41a2-97f1-fb5bca9ac415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Swivel
• Version Model Number: HP2069
• Catalog Number: EZ-Swivel N E6
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990010306455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101551

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

[00990010306455]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-04
• Device Publish Date: 2023-12-27

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• 00990010301610: EZ-Swivel PD M4, 4 Holes
• 00990010301603: EZ-Swivel PD B2, 2 Holes
• 00990010301481: EZ-Swivel QD B2, 2 Holes
• 00990010301474: EZ-Swivel QD M4, 4 Holes
• 00990010301429: EZ-Swivel K E6, 6 Holes
• 00990010301412: EZ-Swivel K M4, 4 Holes
• 00990010306455: EZ-Swivel N E6, Coupler E6, 6 Holes, Optic