Silan-IT

GUDID 03760260223119

Cross-linking agent containing silan agent to improve adhesion

ITENA CLINICAL

Dental prosthesis priming agent

• Primary Device ID: 03760260223119
• NIH Device Record Key: 49e79975-b344-4689-b280-1ec2f1b52573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silan-IT
• Version Model Number: SILAN-IT
• 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

Customer Support Contacts

• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com
• Phone: +330764852012
• Email: qara@itena-clinical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable, do not handle or store near a heat source / electrical source / exit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760260223119 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

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