Silan-IT

GUDID 03760260223119

Cross-linking agent containing silan agent to improve adhesion

ITENA CLINICAL

Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent 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