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 Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive Dental impression material adhesive 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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