Z-Evo

GUDID 00810092938637

Endodontic motor with integrated apex locator with continuous and reciprocating rotation.

NUSMILE, LTD.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 00810092938637
• NIH Device Record Key: a3a023fe-c420-43b8-a4fa-3a8774a81f2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-Evo
• Version Model Number: 6080241
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810092938637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201993

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-19
• Device Publish Date: 2022-07-11

Devices Manufactured by NUSMILE, LTD.

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• 00810118105548 - NuSmile BioFlx Narrow - First Primary Molar - Starter Kit: 2024-08-22 NuSmile BioFlx Narrow - First Primary Molar - Starter Kit - 32 Crowns
• 00810118104565 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade
• 00810118104572 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade
• 00810118104589 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade
• 00810118104596 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade
• 00810118104602 - NuSmile Signature Anterior Replacement Crown: 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade