SILANEA SILSER1.2-5

GUDID 03760260223072

ITENA CLINICAL

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• Primary Device ID: 03760260223072
• NIH Device Record Key: d6c04a6f-8cca-455d-bffe-c6bd44e704f2
• Commercial Distribution Discontinuation: 2021-04-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SILANEA
• Version Model Number: SILSER1.2-5
• Catalog Number: SILSER1.2-5
• Company DUNS: 262150858
• Company Name: ITENA CLINICAL
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760260223072 [Primary]

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-10-19
• Device Publish Date: 2016-10-15

Devices Manufactured by ITENA CLINICAL

• 03760260220385 - MTA BIOREP: 2022-12-01
• 03760260220392 - MTA BIOREP: 2022-12-01
• 03760260220408 - MTA BIOSEAL: 2022-12-01
• 03760260220002 - REFLECTYS: 2022-11-10
• 03760260220019 - REFLECTYS: 2022-11-10
• 03760260220026 - REFLECTYS: 2022-11-10
• 03760260220033 - REFLECTYS: 2022-11-10
• 03760260220040 - REFLECTYS: 2022-11-10