Xeno® IV Dual Cure Self-Etching Dental Adhesive 668012

GUDID D0026680121

Xeno® IV Dual Cure Self-Etching Dental Adhesive Evaluator Package

DENTSPLY INTERNATIONAL INC.

Dental impression material adhesive

• Primary Device ID: D0026680121
• NIH Device Record Key: f422e8f7-7f2c-4f33-a353-e8f01a7b6256
• Commercial Distribution Discontinuation: 2019-10-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Xeno® IV Dual Cure Self-Etching Dental Adhesive
• Version Model Number: 668012
• Catalog Number: 668012
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• 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: true
• 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: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026680121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041343

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: 4
• Public Version Date: 2022-10-03
• Device Publish Date: 2016-09-21

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