Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System 666245

GUDID D0026662450

Integrity Temporary Crown and Bridge Material, Bleach White, Cartridge Refill Package

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D0026662450
• NIH Device Record Key: ade6ae76-c4cd-4e89-86f6-18e41c6fbe62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System
• Version Model Number: 666245
• Catalog Number: 666245
• 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: 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: +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
• 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

• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0
• Weight: 76 Gram
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• 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	D0026662450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013674

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, 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: 2021-10-29
• Device Publish Date: 2016-09-21

On-Brand Devices [Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System]

• D0026663700: Integrity Temporary Crown and Bridge Material, C2, Cartridge Refill Package
• D0026663600: Integrity Temporary Crown and Bridge Material, A3, Cartridge Refill Package
• D0026662450: Integrity Temporary Crown and Bridge Material, Bleach White, Cartridge Refill Package
• D0026662400: Integrity Temporary Crown and Bridge Material, B1, Cartridge Refill Package
• D0026662300: Integrity Temporary Crown and Bridge Material, A3.5, Cartridge Refill Package
• D0026662200: Integrity Temporary Crown and Bridge Material, A2, Cartridge Refill Package
• D0026662100: Integrity Temporary Crown and Bridge Material, A1, Cartridge Refill Package