Z-Evo

GUDID 00810092938637

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

NUSMILE, LTD.

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• 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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• 00810118104374 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3)
• 00810118104381 - Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3)
• 00810118104398 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1)
• 00810118104404 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2)
• 00810118104411 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3)
• 00810118104428 - Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3): 2024-02-20 Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3)