Endo-Eze MTA Flow Repair Cement White Gel

GUDID 00810092938446

Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810092938446
• NIH Device Record Key: 680fbed4-317d-44bf-bd9f-256cce5c75a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Eze MTA Flow Repair Cement White Gel
• Version Model Number: 14467
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810092938446 [Primary]

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: 2021-12-29
• Device Publish Date: 2021-12-21

Devices Manufactured by NUSMILE, LTD.

• 00810118106415 - Avalon Biomed NeoSolv: 2025-03-27 Avalon Biomed NeoSolv - 4 oz Bottle
• 00810118106422 - Avalon Biomed NeoSolv: 2025-03-27 Avalon Biomed NeoSolv - 8 oz Bottle
• 00810118103667 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Strawberry
• 00810118103674 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Mint
• 00810118103681 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 50 pk Kit - Bubblegum
• 00810118103698 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Strawberry
• 00810118103704 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Mint
• 00810118103711 - NuSmile NuNamel Varnish: 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum